Evera™ S DR DDBC3D4 (UDI 00643169018020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00643169018020), received between Dec 9, 2016 and Jun 29, 2026 — classified as 7 deaths, 91 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (42 reports).

2 FDA recall records name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · FDA record ↗

2. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0587-2018 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO SYNCOPE. A DEVICE INTERROGATION INDICATED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TREATED AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) THAT MAY HAVE BEEN VENTRICULAR TACHYCARDIA (VT). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING THE EPISODE THOUGH THERE APPEARED TO BE NO IMPACT TO DEVICE FUNCTION. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 25649637 ↗
• MalfunctionMay 20, 2026Electromagnetic Interference; Device Sensing Problem

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE RESULTED IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISCLASSIFYING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228120 ↗
• InjuryAug 21, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE INAPPROPRIATELY DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING AND THE DEVICE FALSELY CLASSIFYING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AS TERMINATED. THE ICD WAS EXPLANTED AND REPLACED. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22866584 ↗
• InjuryJul 14, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) BUT THE RHYTHM WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22500204 ↗
• InjuryFeb 20, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED FAULTY MAGNET RESPONSE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423173 ↗
• InjuryNov 7, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A REVIEW OF STORED ELECTROGRAMS REVEALED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FLUTTER WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE PATIENT RECEIVED MEDICATION CHANGES. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632985 ↗
• MalfunctionJul 12, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN EXTERNAL TELEMETRY MONITOR TRIGGERED AN ALARM, AND IT WAS NOTED THAT PACING SPIKES WERE SEEN DURING AND IN BETWEEN QRS COMPLEXES. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WASN¿T PACING FOR FOUR (4) BEATS AND THEN KICKED BACK IN. THE PATIENT WAS ASYMPTOMATIC, AND A 12-LEAD ELECTROCARDIOGRAM (ECG) SHOWED SINUS RHYTHM. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19735372 ↗
• InjuryJun 27, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT WHILE UNDERGOING A PROCEDURE, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO POSSIBLE NOISE. IT WAS NOTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). OVERSENSING ON THE ATRIAL AND VENTRICULAR LEAD WERE OBSERVED, CAUSING POSSIBLE FALSE ARRHYTHMIA DETECTION AT TIMES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19624535 ↗
• InjuryMay 8, 2024Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED FEELING A SHOCK. REVIEW OF A REMOTE TRANSMISSION SHOWED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ATTEMPTED TO DELIVER 13 SHOCKS FOR THREE EPISODES OF WHAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. REVIEW OF THE DATA FROM THE TREATED EPISODES SHOWED SHORT CIRCUIT PROTECTION (SCP) WAS TRIGGERED FOR ALL 13 HIGH-VOLTAGE THERAPIES, RESULTING IN NO HIGH-VOLTAGE ENERGY OR LESS THAN THE PROGRAMMED HIGH-VOLTAGE ENERGY BEING DELIVERED. FURTHER REVIEW OF THE DEVICE DATA SHOWED EVIDENCE THAT THE SCP EVENTS WERE RELATED TO AN ICD ISSUE AS THERE WAS NO INDICATION OF A LEAD INTEGRITY ISSUE THAT WOULD HAVE CAUSED THE SCP EVENTS. DETECTIONS WERE PROGRAMMED OFF, AND THE ICD WAS LATER EXPLANTED AND REPLACED WITH NORMAL LEAD TESTING NOTED VIA ANALYZER DURING THE CHANGEOUT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19270174 ↗
• MalfunctionApr 22, 2024Mechanical Problem; Damaged Thread; Mechanical Problem; Damaged Thread

  IT WAS REPORTED THAT DURING A PLANNED DEVICE CHANGEOUT PROCEDURE THAT THE WRENCH WAS UNABLE TO ACTIVATE THE SETSCREW, UNABLE TO GET INTO SCREW AS THE SCREW WAS MISALIGNED AND SIDEWAYS IN HEADER.  THE SETSCREW THREADS WERE DAMAGED OR STRIPPED AND COULD NOT TURN. THE DOCTOR HAD TO CUT THE SILICONE TO REMOVE THE SCREW AND THEN PULL LEAD OUT FROM HEADER. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19157692 ↗
• InjuryFeb 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE IN A COMA FOR 145 DAYS, AND HOSPITALIZED FOR TWO YEARS. THE PATIENT BELIEVES THAT THEIR DEVICE HAS STOPPED WORKING BECAUSE THEY "FELT IT PACING ALL THIS TIME". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Coma

  MAUDE report 18639504 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SEPSIS/SEPTICEMIA, AND THE SOURCE OF THE INFECTION WAS UNKNOWN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Sepsis

  MAUDE report 18440062 ↗
• MalfunctionDec 27, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HEARD AN AUDIBLE ALERT. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). ADDITIONALLY, THE RV LEAD DISPLAYED OVERSENSING OF NOISE. THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR HIGH ATRIAL THRESHOLDS, WHICH WERE ALSO NOTED TO BE VARIABLE. FURTHER, THE RA LEAD DISPLAYED SMALL P WAVES AND ATRIAL UNDERSENSING WITH A SUBSEQUENT LACK OF DETECTION AND TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND INAPPROPRIATE ATRIAL PACING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RA LEAD, AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18404630 ↗
• MalfunctionOct 26, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT SEND A MANUAL TRANSMISSION TO THE REMOTE MONITOR NETWORK. TROUBLESHOOTING WAS PERFORMED BUT TO NO AVAIL. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014604 ↗
• InjurySep 13, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT TACHYCARDIA THERAPIES ARE OFF AS THE PATIENT IS UNDER HOSPICE CARE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17739262 ↗
• MalfunctionAug 14, 2023Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AND ELEVATED SENSING INTEGRITY COUNTER (SIC) WAS OBSERVED. IT WAS NOTED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR A BIOPSY ON THE RIGHT SIDE OF THEIR CHEST AT THE TIME OF THE ALERT WHICH WAS LIKELY TRIGGERED DUE TO THE PROCEDURE AND USE OF CAUTERY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542625 ↗
• InjuryAug 10, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). IN ADDITION, UNDERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH THRESHOLDS. THE ICD, RA LEAD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17499526 ↗
• InjuryJul 24, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT RECEIVED A SHOCK FOR DETECTED VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR HIGH THRESHOLDS. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17380061 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17346969 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17343259 ↗
• InjuryJun 30, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE ARRHYTHMIA WAS VERIFIED AS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17239257 ↗
• DeathJun 15, 2023Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY PRIOR TO RECOMMENDED REPLACEMENT DUE TO INABILITY TO GUARANTEE THE DEVICE WILL OPERATE AS DESIGNED. THE PATIENT¿S OFFICIAL CAUSE OF DEATH IS ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE.

  Patient problems: Arteriosclerosis/ Atherosclerosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135785 ↗
• InjuryMay 25, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17002042 ↗
• InjuryJan 31, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) OVERSENSING WAS NOTED ON THE RVTIP TO RVRING ELECTROGRAMS (EGM) DURING HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND THAT THE EGMS SHOWED ABNORMAL PACING. THE PATIENT WAS BROUGHT IN TO THE CLINIC AND TESTING WAS PERFORMED BUT THE OVERSENSING COULD NOT BE REPRODUCED. IN ADDITION, A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HRNS EPISODES AND SENSING INTEGRITY COUNTER (SIC) DURING A SHOULDER SURGERY WHERE THE MAGNET HAD SLIPPED OFF. THIS RESULTED IN THE PATIENT RECEIVING SHOCKS DUE TO THE OVERSENSING OF CAUTERY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16272676 ↗
• InjuryJan 26, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING THE FIRST HIGH VOLTAGE THERAPY DELIVERED FOR AN EPISODE OF FAST VENTRICULAR TACHYCARDIA (FVT) RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED. THE SECOND HIGH VOLTAGE THERAPY WAS DELIVERED BY THE ICD AND RIGHT VENTRICULAR (RV) LEAD WITH THE FULL PROGRAMMED HIGH VOLTAGE ENERGY, HOWEVER THE ARRHYTHMIA WAS NOT SUCCESSFULLY TERMINATED. ADDITIONALLY, THE CLINICAL DATA SHOWED THE RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE TREND WAS ABNORMALLY VARIABLE, AND LEAD NOISE WAS OBSERVED ON SOME RECORDED EPISODES SUGGESTIVE OF AN RA LEAD FRACTURE. THE ICD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED AND REPLACED WHEN THE PATIENT WAS UPGRADED TO A BIVENTRICULAR DEFIBRILLATOR SYSTEM, AND THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 16246386 ↗