Evera™ S DR DDBC3D4 (UDI 00643169720381)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169720381), received between Apr 2, 2019 and Jul 26, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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. May 10, 2023Open, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1710-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED, THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY, DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). INCORRECTLY, CLASSIFYING AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR FIBRILLATION (VF). 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 19841358 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTEREMIA INFECTION WITH LEAD VEGETATION. THE ORGANISM WAS IDENTIFIED AS VIRIDANS STREPTOCOCCI. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED, AND A TEMPORARY PACING LEAD WAS USED FOR ABOUT A WEEK BEFORE A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 19278829 ↗
• InjuryFeb 28, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF), BUT THE RHYTHM WAS SUSPECTED TO BE ATR IAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 18796958 ↗
• InjuryNov 30, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 18238752 ↗
• MalfunctionOct 27, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE DEVICE DELIVERED A TOTAL OF 7 SHOCKS AND 17 ATP SEQUENCES FOR AN EPISODE THAT WAS CLASSIFIED BY THE DEVICE AS VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT SHORT CIRCUIT PROTECTION OCCURRED DURING ONE OF THE SHOCKS RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. 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 15684733 ↗
• MalfunctionFeb 21, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT GRAY BAR FOR THE BATTERY OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OCCURRED UPON INTERROGATION PRIOR TO USE. THE ICD WAS NOT USED FOR ANY CASE. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9738399 ↗
• MalfunctionApr 2, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED GRAY BAR ON INTERROGATION, INDICATING LOW TELEMETRY BATTERY VOLTAGE. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8475275 ↗