Evera™ S VR DVBC3D1 (UDI 00643169929852)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169929852), received between Feb 8, 2018 and Jun 4, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 FDA recall record name this device's identifier.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 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) WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 22144954 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS NOTED THAT AN ECHOCARDIOGRAM SHOWED A LARGE VEGETATION ON THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21218327 ↗
• InjuryNov 26, 2019Adverse 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 SYSTEMIC INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9377460 ↗
• MalfunctionMar 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY VOLTAGE WAS TOO LOW TO BE CONSIDERED FOR IMPLANT AND THE DEVICE DID NOT RECOVER AFTER SITTING AT ROOM TEMPERATURE. THE DEVICE WAS NEVER IMPLANTED AND NO PATIENT WAS INVOLVED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8449166 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING, THE ICD WAS REPROGRAMMED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, DEVICE THERAPIES WERE TURNED OFF TO PRECLUDE HARM TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416828 ↗
• MalfunctionFeb 8, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED DUE TO A SETSCREW PROBLEM. THE SETSCREW WAS UNABLE TO BE SEATED INTO THREADS. THE ICD WAS REMOVED FROM IMPLANT AND A NEW ICD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254107 ↗