Evera™ S VR DVBC3D1 (UDI 00643169017900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00643169017900), received between Apr 6, 2017 and Sep 16, 2026 — classified as 2 deaths, 77 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received potential inappropriate therapy for Supra Ventricular Tachycardia (SVT), that the device d etected as Ventricular Tachycardia (VT). 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 50791544 ↗
• InjuryJun 25, 2026Delayed Charge Time

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE RESULTING IN THE PATIENT RECEIVING AN INAPPROPRIATE SHOCK. RV OVERSENSING, NOISE, AND OUT OF RANGE PACING IMPEDANCE WERE ALSO NOTED. ADDITIONALLY, A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALSO HAD A CHARGE CIRCUIT TIMEOUT. DETECTIONS WERE PROGRAMMED OFF. THE ICD AND 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

  MAUDE report 25626984 ↗
• InjuryOct 23, 2025Premature Discharge of Battery; Reset Problem; Premature Discharge of Battery; Reset Problem

  IT WAS REPORTED THAT THERE WAS MULTIPLE ELECTRICAL RESETS AND PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO NOTED THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION, "JUMPING OR TWITCHING IN THE CHEST," AND PALPITATIONS. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373821 ↗
• InjuryOct 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) DUE TO PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE ICD COULD NOT BE INTERROGATED DUE THE A DEAD BATTERY. 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 23285550 ↗
• MalfunctionSep 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD¿S SENSING INTEGRITY COUNTER (SIC) WAS ELEVATED. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. 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 23088968 ↗
• InjuryAug 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT OFF FOR THE WRONG REASONS WHEN THEY HAD CANCER TREATMENTS AND THE ICD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811418 ↗
• InjuryJun 27, 2025Adverse 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22345607 ↗
• InjuryMay 22, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD WAVELET DISCRIMINATOR FOR VENTRICULAR TACHYCARDIA (VT). THE DEVICE CLASSIFIED THE EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 22073091 ↗
• InjuryFeb 6, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ¿PATIENT CODED¿ WHEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STABILITY DETECTION INAPPROPRIATELY W ITHHELD CAUSING A DELAY IN THERAPY FOR VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21324429 ↗
• InjuryFeb 3, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE INAPPROPRIATELY DETECTED THE PATIENT'S RHYTHM AS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21294556 ↗
• MalfunctionOct 31, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED USING THE MOBILE PROGRAMMER. THE ICD AND MOBILE PROGRAMMER 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 20580132 ↗
• DeathOct 25, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT HAD EXPERIENCED DIZZINESS AND COLLAPSED A SHORT TIME LATER. THE FAMILY MEMBER PERFORMED CARDIOPULMONARY RESUSCITATION, AND THE PATIENT WAS TAKEN TO THE HOSPITAL AND LATER DIED. THE FAMILY MEMBER INDICATED THAT THE PATIENT'S DEATH WAS RELATED TO THE DEVICE NOT DELIVERING A SHOCK DURING A CARDIAC EVENT, AND ALSO INDICATED THAT THEY HAD SUBSTANTIAL DOCUMENTATION OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MALFUNCTION. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC.

  Patient problems: Dizziness; Fall; Insufficient Information

  MAUDE report 20538983 ↗
• MalfunctionAug 28, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE AND TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR SIC AND HIGH RATE NON-SUSTAINED EPISODES. 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 20091803 ↗
• InjuryAug 26, 2024Pacing 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) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF) EPISODES THAT WERE POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE 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 20071013 ↗
• MalfunctionApr 11, 2024Premature Discharge of Battery; Battery Problem: Low Impedance; Premature Discharge of Battery; Battery Problem: Low Impedance

  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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091196 ↗
• InjuryMar 6, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INTERROGATION SHOWED THAT THE ICD HAD TRIGGERED THE END OF SERVICE (EOS) INDICATOR WITH ALERTS FOR CHARGE CIRCUIT INACTIVE AND CHARGE CIRCUIT TIMEOUT FOLLOWING DELIVERY OF 32 DEFIBRILLATION SHOCKS OVER THE PAST TWO DAYS. THE ICD WAS LATER EXPLANTED AND REPLACED WHEN THE PATIENT WAS UPGRADED TO A BIVENTRICULAR DEFIBRILLATION SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848478 ↗
• MalfunctionFeb 16, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED UNEXPLAINED DROPS IN BATTERY VOLTAGE AND DECREASES IN EXPECTED LONGEVITY. 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 18722820 ↗
• InjuryJan 22, 2024Adverse 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 REMOVED DUE TO AN INFECTION IDENTIFIED AS FROM THE STREPTOCOCCUS MITIS GROUP. A NEW SYSTEM LATER IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 18553408 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS COMPLETELY REMOVED AND REPLACED DUE TO INFECTION, AND ALSO THAT THEIR DEVICE WAS DEFECTIVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18434644 ↗
• MalfunctionNov 20, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR TACHYCARDIA (VT) AND PROVIDED ANTI-TACHYCARDIA PACING. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT), MEANING THE THERAPY WAS INAPPROPRIATE. THE DEVICE REMAINS IN USE AND APPEARS TO BE CURRENTLY FUNCTIONING AS PROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171812 ↗
• InjurySep 25, 2023Adverse 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 A SUSPECTED INFECTION. T HE ORGANISM OF THE INFECTION WAS CONFIRMED TO BE METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) WITH BACTEREMIA AND SEPSIS/SEPTICEMIA REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Sepsis

  MAUDE report 17808149 ↗
• InjuryJul 10, 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 THE PATIENT EXPERIENCING SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 17287384 ↗
• InjuryMay 25, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THE ICD WAS ABLE TO BE INTERROGATED WITHOUT ISSUE. THE DEVICE WAS REMOVED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001130 ↗
• InjuryMay 16, 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16939469 ↗
• InjuryApr 13, 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) WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16732531 ↗