St Jude Medical SJMRFB RF implantable medical device User Manual

St. Jude Medical RF implantable medical device

Users Manual

XXXX XXXX XXXX Reference Manual 1-1Accent™SR Model PM1110SR RF Model PM1210DR Model PM2110DR RF Model PM2210Pulse GeneratorsAnthem™Model PM3110RF Model PM3210Cardiac Resynchronization Therapy Device,Pulse GeneratorUser’s Manual-- Draft --

1-2CAUTIONFederal (USA) law restricts this device to sale by oron the order of a physician.Proposition 65, a State of California voter initiative, requires the fol-lowing notice: WARNING: This product and its packaging have been sterilized with ethylene oxide. This packaging may expose you to ethyl-ene oxide, a chemical known to the state of California to cause cancer or birth defects or other reproductive harm.© 2009 St. Jude Medical Cardiac Rhythm Management Division.All Rights Reserved.Unless otherwise noted, ® or ™ indicates that the name is a trademark of,or licensed to, St. Jude Medical, Inc. or its subsidiaries.-- Draft --

$XXXX XXXX XXXX Reference Manual 1-1Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 1Device DescriptionThis manual describes the following St. Jude Medical™ devices: The pulse generator, along with compatible, commercially available leads, con-stitutes the implantable portion of the pulse generator and CRT-P systems. The lead systems are implanted using either transvenous or transthoracic tech-niques. These devices can be programmed with Merlin Patient Care System equipped with Model 3330 version 7.1 (or greater) software. For information on programming, refer to the programmer’s on-screen help.Indications and UsageImplantation of Anthem™ and Anthem RF devices is indicated for:• Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure.• The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration.Implantation of Accent™, Accent RF, Anthem, and Anthem RF devices is indi-cated in one or more of the following permanent conditions:• Syncope• Presyncope•Fatigue• DisorientationName Model Number DescriptionAccent SR PM1110 Single-chamber pulse generatorAccent SR RF PM1210 Single-chamber pulse generator with RF telemetryAccent™ DR PM2110 Dual-chamber pulse generatorAccent DR RF PM2210 Dual-chamber pulse generator with RF telemetryAnthem™ PM3110 CRT-P pulse generatorAnthem RF PM3210 CRT-P pulse generator with RF telemetryTable 1. Accent and Anthem device descriptions-- Draft --$

1-2 Contraindications2 Contraindications• Or any combination of those symptoms.Rate-Modulated Pacing is indicated for patients with chronotropic incompe-tence,1 and for those who would benefit from increased stimulation rates con-current with physical activity.Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem, and Anthem RF devices only) is indicated for those patients exhibiting:• Sick sinus syndrome• Chronic, symptomatic second- and third-degree AV block• Recurrent Adams-Stokes syndrome• Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.Ventricular Pacing is indicated for patients with significant bradycardia and:• Normal sinus rhythm with only rare episodes of A-V block or sinus arrest• Chronic atrial fibrillation• Severe physical disability.AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for suppression of paroxysmal or per-sistent atrial fibrillation episodes in patients with one or more of the above pac-ing indications. For specific indications associated with individual modes, refer to the program-mer’s on-screen help.ContraindicationsImplanted Cardioverter-Defibrillator (ICD). Accent™, Accent RF, Anthem™, Anthem RF devices are contraindicated in patients with an implanted cardioverter-defibrillator.Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient.1. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 min-1 during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197 — (0.56 x age). Gwinn N, Leman R, Kratz J, et al. Chronotropic incompetence: A common and progressive finding in pacemaker patients. American Heart Journal 1992; 123:1216-19.-- Draft --

XXXX XXXX XXXX Reference Manual 1-3Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 3AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem, Anthem RF devices only) stimulation is not recommended in patients who can-not tolerate high atrial-rate stimulation. Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem, Anthem RF devices only), though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients.Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventric-ular pacing.Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction.For specific contraindications associated with individual modes, refer to the pro-grammer’s on-screen help.Warnings and PrecautionsTo prevent permanent damage to the device and tissue damage at the elec-trode/tissue interface:• Electrosurgery. Do not use electrosurgical devices in the vicinity of an implanted device. If electrocautery is necessary, use a bipolar cauterizer or place the indifferent electrode as far from the device as possible.• Lithotripsy. Do not focus a lithotripsy beam within 6 inches of the device. Program the device to Sensor Off prior to lithotripsy to prevent inappropri-ate increases in pacing rate. A thorough assessment of device function with special attention to the sensor should be performed following expo-sure to lithotripsy.• Therapeutic Radiation. Do not use ionizing radiation in the vicinity of an implanted device. Radiation therapy may damage the electronic circuitry of the device.• Ultrasound Treatment. Do not use therapeutic ultrasound within 6 inches of the device.• Ventricular Sensing. In Anthem™ and Anthem RF devices, Ventricular Sen-sitivity should be programmed to the highest setting (lowest sensitivity) that will provide ventricular sensing with adequate sensing margin. Left ventricular lead dislodgement, to a position near the atria, can result in atrial oversensing and ventricular inhibition.Perform a thorough assessment of device function following exposure to any of the above.-- Draft --

$1-4 Warnings and Precautions4 Warnings and PrecautionsBackup VVI Operation. In rare instances, the device may revert to Backup VVI operation at the programmed settings listed in Table 2. These values are not programmable. When the device has reverted to Backup VVI operation, the programmer dis-plays a pop-up message indicating that the device is operating at the Backup VVI values. Press [Continue] and follow the on-screen instructions.Elective Replacement Indicator (ERI). At ERI, the nominal life of the device is three months. When the device exhibits signs of ERI, described on page 18, it should be replaced expeditiously.Patient follow-up visits should be scheduled at an appropriate frequency so that ERI can be detected well before End-of-Life (EOL).Noninvasive Programmed Stimulation (NIPS). Life-threatening ventricular tachycardia or fibrillation may occur during NIPS, therefore: (1) closely monitor the patient, and (2) make defibrillation and resuscitation equipment, and trained personnel, readily available during testing. Only physicians trained in tachycardia induction and reversion protocols should use NIPS. For more infor-mation on NIPS, refer to the programmer’s on-screen help.Ventricular Support Pacing during NIPS testing (Accent Model PM2110, Accent RF Model PM2210, Anthem, and Anthem RF devices only) is delivered Parameter ValueAccent™ Anthem™Mode VVI VVIBase Rate 67.5 ppm 67.5 ppmVentricular Pacing Chamber NA LV —> RVPulse Configuration Unipolar RV Unipolar TipLV Unipolar TipSense Configuration Unipolar Tip RV Unipolar TipPulse Amplitude 5.0 V 5.0 VPulse Width 0.6 ms 0.6 msRefractory Period 337 ms 337 msSensitivity 2.0 mV 2.0 mVInterventricular Delay NA 16 msTable 2. Backup VVI Settings-- Draft --$

XXXX XXXX XXXX Reference Manual 1-5Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 5in the VOO mode. The specific indications and contraindications for VOO mode can be found on the programmer’s on-screen help.PrecautionsFor single use only.Device Communication. Communication with the device can be affected by electrical interference and strong magnetic fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the pro-grammer. If the problem persists, contact St. Jude Medical.Suboptimal RF Communication.2 The Merlin® PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the programmer and the Merlin Antenna. Below is a list of potential causes to sub-optimal radio communication:CT Scans. CT scans, due to their increased power levels and long exposure times, have the remote possibility of interfering with implanted devices. The potential interference is transient and occurs only when the X-ray signal is present. Continuous exposure may cause a temporary sensor rate increase. In 2. Available in Accent RF and Anthem RF devices only.Possible Causes SolutionsThe Merlin Antenna orientation/location is suboptimal. Move or reorient the Merlin Antenna slightly. Make sure that the front of the Merlin Antenna faces the implantable device.People or objects interfere with the communication between the Merlin Antenna and the device. Make sure that the space between the Merlin Antenna and the device is free from interfering objects/people.The Merlin Antenna is too far away from the device. Move the Merlin Antenna closer to the device. Someone is holding the Merlin Antenna. Place the Merlin Antenna on a flat surface. Do not hold the Merlin Antenna.Other products in the vicinity are causing electromagnetic interference (EMI).Power off or remove equipment that could cause EMI.The Merlin Antenna cable is wound around the Merlin Antenna. Make sure the Merlin Antenna cable is not wound around the Merlin Antenna.Table 3. Possible causes and solutions for suboptimal RF communication-- Draft --

1-6 Sterilization, Storage and Handling6 Sterilization, Storage and Handlingaddition, there is a remote possibility for a device to intermittently oversense while the CT scanning beam is directly over the implanted device.Sterilization, Storage and HandlingSterilization. The package contents have been sterilized with ethylene oxide before shipment. This device is for single use only and is not intended to be res-terilized. If the sterile package has been compromised, contact St. Jude Medical.Mechanical Shock. St. Jude Medical® devices are ruggedly constructed. How-ever, if you suspect the device has been damaged, do not implant it; return it to St. Jude Medical.Temperature. Do not subject the pulse generator to temperatures above 50ºC (122ºF) or below –5ºC (23ºF). Exposure to temperatures below 0ºC may cause false ERI indications. Following exposure to extreme temperatures, warm the device to room temperature. If ERI indications are still present, return the pulse generator to St. Jude Medical.Incineration. Do not incinerate the device.Preparation for ImplantationPackage Label. Before opening the sterile package, carefully read the label and verify that the package contains the desired device.Verifying Operation. Before opening the sterile package, verify that the device is operating properly by interrogating it in the package. Remove the magnet and establish communication:• Inductive communication. Position the Merlin® PCS telemetry wand over the package and select “Interrogate.” • RF communication. To establish RF communication between the device and the programmer and to troubleshoot communications problems, you must first attach the RF Antenna to the programmer. Please refer to the Merlin™ Patient Care System User’s Manual that accompanies the pro-grammer and the Merlin Antenna. Use the telemetry strength indicators to evaluate the communication.If the device is RF-compatible, an icon in the upper left-hand corner of the screen during the programming session indicates the status of the RF com-munication link. If an RF icon does not appear on the screen during the session, the device is not RF-compatible. Once you have established tele-metery, select “Interrogate.”If The unit’s Measured Data will be displayed on the FastPath® Summary screen and should indicate normal voltage and battery status, and the programmed -- Draft --

XXXX XXXX XXXX Reference Manual 1-7Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 7parameters should be identical to the Shipped Settings displayed on the pro-grammer’s on-screen help.Package Integrity. Ensure that the package has not been opened or in any way compromised. If damage is suspected, return it to the manufacturer.“Use Before” Date. Do not implant the device after the “use before” date printed on the label.Opening the Package. If interrogation of the device in its sterile packaging indicates normal functioning, remove it from the package. The package’s outer tray can be opened in nonsterile surroundings. However, when opening the inner tray, complete sterile technique must be observed.Pre-Implant TestingCompatible Pacing Leads. These devices accept unipolar or bipolar IS-1 short terminal pin leads. Use only St. Jude Medical® leads as the left ventricular lead in Anthem™ and Anthem RF devices. Prior to implantation, make sure leads fit easily and snugly into the device header.Pacing System Analyzer. Before implantation, you may wish to test the device using a compatible pacing system analyzer (PSA) with calibrated sensitiv-ity and output settings. When the probe is attached to the device’s connector, the programmed parameters should be identical to the Shipped Settings dis-played on the programmer’s on-screen help.Adaptor Probes. Use only IS-1 PSA cable adaptor probes when testing the device. Other probes may damage the connector.Capture/Sensing Thresholds. Capture and sensing thresholds should be determined with a PSA before implanting the device. Connect the negative (black) PSA terminal to the portion of the lead terminal pin corresponding to the tip electrode. The positive (red) terminal should be connected to the ring electrode portion of the lead pin for bipolar leads or to an indifferent electrode. For more information on conducting capture and sensing threshold tests, please consult the PSA technical manual.Establishing Baseline Ventricular Capture/Sensing Thresholds (Anthem, Anthem RF devices). After the leads have been implanted and before they are connected to the device, separately identify and document the baseline mor-phology for capture and sensing thresholds for each ventricular lead. Once baselines are established, determine if the ECG or IEGM recordings can help discriminate biventricular capture, and negative depolarizations for each lead. In a cardiac resynchronization therapy system, the ECG may display two distinct capture loss morphologies, because the left and right chambers often have dif-ferent pacing thresholds. To ensure that the device is losing capture on both sides of the heart, allow the test to run until a marked change in morphology occurs, indicating capture loss on both sides.-- Draft --

1-8 Implantation8ImplantationImplantationVentricular Leads with Polished Platinum Tip Electrodes (Anthem™ and Anthem RF devices only). Pairing a ventricular lead with a polished platinum tip electrode with a ventricular lead with a tip electrode of a different material may create a source impedance mismatch that could adversely affect sensing.Data Transmission. Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1.25 cm of bone unless you cannot avoid it.Case Markings. Examine the markings on the device case and verify proper atrial and ventricular connection.Setscrew. Exercise caution when turning the setscrew, which may be backed out of the connector if turned counter-clockwise for more than two rotations.ProgrammingProgrammer. These devices can be interrogated and programmed with the Merlin® Patient Care System equipped with Model 3330 version 7.1 (or greater) software. For a list of programmable parameters and their programmable values, refer to the programmer’s on-screen help.Setting Lead Type. When you interrogate the device for the first time, the programmer will prompt you to set the Lead Type. (In Anthem™ and Anthem RF devices, the right and left ventricular lead types are independently set.) Because some parameters are determined by the Lead Type (for example, Pulse Configuration), you should set this parameter when the device is implanted.Lead Impedance Values. In Anthem and Anthem RF devices, independent lead impedance values are displayed for the RV and LV leads.Ventricular Pulse Amplitudes and Pulse Widths. In Anthem and Anthem RF devices, the right and left ventricular pulse amplitudes and pulse widths are independently programmable. The pulse amplitude should be evaluated in each chamber accordingly. Typically, capture thresholds are higher in the left ventricle.Follow-up Capture Threshold Measurements. In Anthem and Anthem RF devices, the RV and LV capture threshold measurements are evaluated inde-pendently. During an RV or LV capture test, you may be able to determine when capture is occurring by noting changes in the ECG morphology. For addi-tional information, refer to the programmer’s on-screen help.AOO(R), VOO(R), and DOO(R) Modes are primarily intended for temporary diagnostic use. Long-term use may result in competitive pacing, inducing potentially dangerous arrhythmias.-- Draft --

XXXX XXXX XXXX Reference Manual 1-9Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 9Off mode is not recommended for patients who would be adversely affected by even a short cessation of device function.Pulse Amplitude. If the AutoCapture™ Pacing System or Cap Confirm are not in use, determine the capture threshold before programming the Pulse Ampli-tude. Program Pulse Amplitude to yield a suitable safety margin for reliable, long-term capture. Reassess capture thresholds periodically.Noninvasive Program Stimulation (NIPS). Atrial or ventricular tachycardia or fibrillation may occur during NIPS. Therefore, (1) closely monitor the patient, and (2) have emergency equipment for cardioversion/defibrillation readily avail-able while conducting NIPS.High-Output Settings. Programming high-output settings or a high Base Rate may shorten the time to ERI. Runaway Protection. Hardware circuitry in the device prevents it from stimu-lating at rates higher than 210 min-1 (± 10 min-1). Sensing Configuration. Sensing tests should be performed whenever changes are made to the sensing configuration.Sensitivity Settings. Careful consideration should be given to patient expo-sure to electromagnetic interference if programming sensitivity greater than 0.5 mV with a bipolar sense configuration setting and 2.0 mV with a unipolar sense configuration setting.Environmental and Medical TherapyHazardsSt. Jude Medical™ devices are equipped with special shielding and filters which significantly reduce the adverse effects of electromagnetic interference (EMI) on the operation of the device.Patients should be directed to exercise reasonable caution in avoidance of strong electric or magnetic fields. If the device inhibits or reverts to asynchro-nous operation while in the presence of electromagnetic interference (EMI), the patient should move away from the EMI source or turn the source off.Advise patients to seek medical guidance before entering environments which could adversely affect the operation of the device, including areas protected by a warning notice preventing entry by pacemaker patients.Medical Procedures and EnvironmentsIn general, pacemaker patients should not be exposed to hospital equipment that produces high electromagnetic field strength signals, such as diathermy machines and electrosurgical units.-- Draft --

1-10 Environmental and Medical Therapy Hazards10 Environmental and Medical Therapy Hazards• External Defibrillation. The electronic circuitry in the device provides protec-tion from defibrillation discharges. Nevertheless, do not place defibrillator paddles directly over the device or pacing lead. Following defibrillation, ensure that the device is operating correctly. • Magnetic Resonance Imaging (MRI). MRI for patients with implantable devices has been contraindicated by MRI manufacturers. Clinicians should carefully weigh the decisions to use MRI with pacemaker patients. Addi-tional safety concerns include: - Magnetic and RF fields produced by MRI may increase pacing rate, inhibit pacing, cause asynchronous pacing or result in pacing at random rates- MRI may result in changes in capture thresholds due to heating of pacing leads- MRI may irreversibly damage the device- Patients should be closely monitored during the MRI- Assess the device function before and after exposure to MRI.• Ionizing Radiation. Therapeutic ionizing radiation (for example, used in lin-ear accelerators and cobalt machines) can permanently damage the device’s circuitry. The effect of ionizing radiation is cumulative; the poten-tial for damage to the device is proportional to the patient’s total radiation dosage. If the patient must be exposed to ionizing radiation, protect the device during the procedure with local radiation shielding. If tissue near the implant site must be irradiated, it may be necessary to move the device to another area. Before and after exposure to radiation, evaluate the device operation to identify any adverse consequences.• Transcutaneous Electrical Nerve Stimulation (TENS). To reduce the possibil-ity of interference with device function, place the TENS electrodes close to one another and as far from the device as possible. Before allowing unre-stricted use of TENS in a home or other setting, screen the patient in a monitored environment for possible interaction.• Therapeutic Diathermy. Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may per-manently damage the device.• Electrosurgical Cautery can induce ventricular arrhythmias and/or fibrilla-tion or may cause asynchronous or inhibited device operation. If use of electrocautery is necessary, the current path and ground plate should be kept as far away from the device and leads as possible. A bipolar cauterizer may minimize these effects. Following electrocautery, conduct a thorough assessment of the device.• RF Ablation. Radiofrequency (RF) ablation in patients with a device may cause any of the following: asychronous pacing above or below the pro-grammed rate; reversion to an asynchronous operation; device electrical reset; or premature triggering of the elective replacement indicator.-- Draft --

XXXX XXXX XXXX Reference Manual 1-11Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 11RF ablation risks may be minimized by: programming a non-rate responsive, asynchronous pacing mode prior to the RF ablation procedure; avoid direct contact between the ablation catheter and the implanted lead or device; posi-tioning the ground plate so that the current pathway does not pass through or near the device system, i.e., place the ground plate under the patient’s but-tocks or legs; having a programmer available; or having external defibrillation equipment available.Patient EnvironmentHigh-Voltage transmission lines and equipment, arc or resistance weld-ers, induction furnaces, and similar equipment may generate substantial EMI fields that may interfere with device operation.Communication Equipment, such as microwave transmitters,3 linear power amplifiers, or high-power amateur transmitters may generate sufficient EMI to interfere with the operation of the device. Advise patients to move away from this equipment to resume normal device operation.Home Appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with device operation. Electric vibrators, razors, and handtools held directly over the device may disturb its operation.Twiddler’s Syndrome. Caution patients against manipulating the implanted device since it may result in lead damage or lead displacement.Patient Activities. Any activities that involve repetitive impacts or jarring (such as horseback riding, jackhammer use, etc.) may increase the pacing rate when the device’s Sensor is programmed On. Caution patients against such activity and program Sensor parameters with these activities in mind.Electronic Article Surveillance (EAS). Advise patients that the Electronic Arti-cle Surveillance/Anti-theft systems or Electronic Article Surveillance (EAS) sys-tems such as those at the point of sale and entrances/exits of stores, libraries, banks, etc., emit signals that may interact with pacemakers and CRT-Ps. It is very unlikely that these systems will interact with their device significantly. How-ever, to minimize the possibility of interaction, advise patients to simply walk through these areas at a normal pace and avoid lingering near or leaning on these systems.No Pacer Symbol. Caution patients implanted with this device to avoid areas marked with the NO PACER symbol.3. Home appliance microwave ovens do not interfere with device operation. -- Draft --

1-12 Explantation12 ExplantationFigure 1. No Pacer SymbolCellular Phones. A St. Jude Medical-designed protective filter in Accent™, Accent RF, Anthem™, and Anthem RF devices prevents cellular phone-gener-ated electromagnetic signals from interfering with the operation of the device.4The device has also been tested for compatibility with handheld wireless trans-mitters in accordance with the requirements of AAMI PC69. This testing cov-ered the operating frequencies (450 MHz - 3 GHz) and pulsed modulation techniques of all of the digital cellular phone technologies in worldwide use today. For more information, you or your patient may wish to contact Technical Service (page 19).ExplantationDo not reuse explanted devices and leads.Clean explanted equipment with +1% sodium hypochlorite, rinse with water, dry.Return the explanted device to the manufacturer. Explant the device before cremation of a deceased patient.Hex wrenches are available for disconnecting a previously implanted device from the indwelling leads. To obtain the wrenches, contact your local St. Jude Medical representative.Potential Adverse EventsThe following are potential complications associated with the use of any pacing system:• Air embolism• Body rejection phenomena• Cardiac tamponade or perforation4. Carrillo R, Williams DB, Traad EA, Schor JS. Electromagnetic filters impeded adverse interference of pacemakers by digital cellular telephones. JACC 1996; 27(2A):15A Abstract 901-22.-- Draft --

$XXXX XXXX XXXX Reference Manual 1-13Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 13• Hematoma, bleeding hematoma, seroma• Formation of fibrotic tissue, local tissue reaction• Inability to interrogate or program due to programmer or device malfunc-tion• Infection/erosion• Interruption of desired pulse generator function due to electrical interfer-ence, either electromyogenic or electromagnetic• Lead malfunction due to conductor fracture or insulation degradation• Loss of capture or sensing due to lead dislodgement or reaction at the elec-trode/tissue interface• Loss of desired pacing and/or sensing due to lead displacement, body reac-tion at electrode interface, or lead malfunction (fracture or damage to insulation)• Loss of normal device function due to battery failure or component mal-function• Pacemaker migration or pocket erosion• Pectoral muscle or diaphragmatic stimulation• Phrenic nerve stimulation• Pneumothorax/hemothorax• Device migration and pocket erosion• Endocarditis• Excessive bleeding• Induced atrial or ventricular arrhythmias• Myocardial irritability• Pericardial effusion• Pericardial rub • Pulmonary edema• Rise in threshold and exit block• Valve damage• Cardiac/coronary sinus dissection (Anthem, Anthem RF devices only)• Cardiac/coronary sinus perforation (Anthem, Anthem RF devices only)• Coronary sinus or cardiac vein thrombosis (Anthem, Anthem RF devices only)-- Draft --$

St Jude Medical SJMRFB RF implantable medical device User Manual

St. Jude Medical RF implantable medical device

Users Manual

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