Evera™ S DR DDBC3D1 (UDI 00643169530287)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169530287), received between Feb 9, 2017 and Dec 11, 2025 — classified as 1 death, 31 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (13 reports).

1 FDA recall record 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  Approximately nine months later, EMI/noise was noted on stored episodes triggering episode misclassification.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780021 ↗
• MalfunctionNov 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514613 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. PURULENT DISCHARGE AND PUS ALONG WITH VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 20453520 ↗
• MalfunctionSep 21, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A LONGEVITY DROP FROM 2.7 YEARS TO 4 MONTHS IN ABOUT A MONTH. THE 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 20275172 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S 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 18809114 ↗
• MalfunctionFeb 12, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE PROCEDURE ON THE DAY OF THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) WAS A LEFT UPPER EXTREMITY FISTULA CREATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685707 ↗
• MalfunctionDec 4, 2023Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS POTENTIAL ELECTROMAGNETIC INTERFERENCE AND OVERSENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) NOTED ON A STORED 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 18256122 ↗
• MalfunctionOct 22, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED VENTRICULAR OVERSENSING ON STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS DURING LEAD IMPEDANCE TESTING. 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 17982386 ↗
• InjurySep 11, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT A FOLLOW UP WITH THE PATIENT'S HEALTHCARE PROVIDER YIELDED THAT THE ANTI-TACHYCARDIA PACING AND SHOCK THERAPY WERE APPROPRIATE FOR A TRUE VT ARRHYTHMIA. THE SHOCK OCCURRED WHILE THE PATIENT WAS DOING YARDWORK. THE PATIENT WAS DIAPHORETIC AND HAD SHORTNESS OF BREATH.

  Patient problems: Diaphoresis; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 17726016 ↗
• MalfunctionAug 31, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI) ON STORED ELECTROGRAMS (EGM). THE TIME OF THE SUSPECTED EMI ALIGNS WHEN THE PATIENT WAS HAVING A PHYSICAL THERAPY PROCEDURE. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS THAT IS CONSISTENT WITH HISTORICAL VALUES. THE ICD AND 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 17661181 ↗
• InjuryJun 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY DEPLETED FROM 2.7 YEARS TO TRIGGERING RECOMMENDED REPLACEMENT TIME (RRT) WITHIN JUST TEN DAYS. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE 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 17117391 ↗
• DeathMar 13, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT FOUR DAYS AFTER THE REMOTE TRANSMISSION INDICATING THE INAPPROPRIATE PACING WAS RECEIVED THE PATIENT EXPIRED DUE TO "MULTIPLE MEDICAL ISSUES".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528990 ↗
• InjuryMar 10, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT ATRIAL UNDER SENSING OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ON THE CURRENT ELECTROGRAM (EGM) AND SOME EPISODES. 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 16526623 ↗
• InjuryJan 30, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) AND DELIVERED HIGH VOLTAGE THERAPY. IT IS SUSPECTED THAT THE THERAPY WAS INAPPROPRIATE. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE INTERMITTENTLY UNDERSENSING DURING ARRHYTHMIA EPISODES. THE ICD 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 16264386 ↗
• MalfunctionOct 31, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE DEVICE DELIVERED A TOTAL OF FOUR SHOCKS FOR TWO EPISODES OF INDUCED VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY FOR THE FIRST THREE SHOCKS. THE FOURTH SHOCK DELIVERED ENERGY AS PROGRAMMED. IT WAS NOTED THAT THE SUPERIOR VENA CAVA (SVC) COIL WAS PROGRAMMED OFF BEFORE THEY PERFORMED THE SECOND INDUCTION. 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 15700988 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY AT DEFIBRILLATION THRESHOLD TESTING, AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. 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 15201862 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY AT DEFIBRILLATION THRESHOLD TESTING, AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. 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 15201467 ↗
• InjuryMar 8, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) EPISODES AND DELIVERED SHOCKS. IT WAS SUSPECTED THAT THE SHOCKS WERE DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AND IS THEREFORE INAPPROPRIATE. THE DEVICE 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 13694778 ↗
• MalfunctionFeb 15, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PACING UNDER THE PROGRAMMED LOWER RATE AND THEIR HEART RATE WAS NOTED TO BE BRADYCARDIC WHEN PUT ON ELECTROCARDIOGRAM (ECG). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 13536859 ↗
• MalfunctionJan 26, 2022Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358210 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR INTERMITTENT CHEST PAIN. THE PATIENT STATED THAT IT "FELT LIKE THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS GOING TO COME OUT OF THEIR CHEST". AN EMERGENCY ROOM PHYSICIAN OBSERVED THAT THE ICD SITE WAS RED AND SWOLLEN WITH AN OPEN AREA WHERE THE ICD COULD BE SEEN. THE ICD SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION WITH EROSION, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Erythema; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 13342877 ↗
• MalfunctionJan 7, 2022Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SOUNDING AN AUDIBLE ALERT. AN INTERROGATION REPORT SHOWS ELECTROMAGNETIC INTERFERENCE (EMI) TRIGGERED A FALSE LEAD INTEGRITY ALERT (LIA). IT WAS NOTED THAT THE PATIENT WAS CLEANING A WATER HEATER AT THE TIME OF THE EPISODE. THE 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 13193426 ↗
• InjuryAug 6, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING AN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AS A FAST VENTRICULAR TACHYCARDIA (FVT) EPISODE. THE DEVICE 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 12288286 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A BLOOD INFECTION. NO FURT HER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11738257 ↗
• MalfunctionJan 21, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEART FAILURE WITH SHORTNESS OF BREATH, WEAKNESS, AND POSSIBLE STROKE WAS SUSPECTED. THERE WAS INTERMITTENT UNDERSENSING CAUSING FALSE TERMINATION OF SOME ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. ADDITIONALLY, IT WAS NOTED THE PATIENT'S HEART WAS IN THE 20'S TO 30'S AND WAS BELOW THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD) PROGRAMMED LOWER RATE. THE RIGHT ATRIAL (RA) LEAD AND ICD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dyspnea; Heart Failure/Congestive Heart Failure; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 11208170 ↗