Evera™ XT VR DVBB1D4 (UDI 00643169017948)Recalls & reported problems

Summary

The FDA's MAUDE database contains 489 adverse event reports that list this exact device (DI 00643169017948), received between Dec 2, 2016 and Jul 8, 2026 — classified as 20 deaths, 352 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (118 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 489 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750634 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION. OVERSENSING OF NOISE WAS OBSERVED. TACHYCARDIA THERAPY WAS PROGRAMMED OFF AND THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REFERRED TO A DIFFERENT FACILITY FOR RV LEAD EXTRACTION/IMPLANT. THE PHYSICIAN DECLINED TO PERFORM THE PROCEDURE DUE TO INFECTION ON THE RV LEAD. 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: Unspecified Infection

  MAUDE report 25642144 ↗
• InjuryJun 9, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR A DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, IT WAS NOTED THAT THE ICD DETECTED RUNS OF VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25447007 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 25247272 ↗
• InjuryMay 19, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 25218443 ↗
• MalfunctionMay 18, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODES THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS 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 25207561 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A SUSPECTED INFECTION AND RECEIVED EXTENSIVE ANTIBIOTIC TREATMENT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25084528 ↗
• InjuryMay 5, 2026Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083308 ↗
• MalfunctionApr 29, 2026Pacing Problem

  IT WAS REPORTED BY A NURSE THAT THE PATIENT¿S HEART RATE WAS DIPPING INTO THE TWENTIES, WHICH WAS NOTED TO BE BELOW BOTH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE. THE CRT-D FUNCTION COULD NOT BE CONFIRMED. BOTH DEVICES REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25038054 ↗
• MalfunctionApr 27, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE WIRELESS TELEMETRY WAS NOT AVAILABLE. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 25003923 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24835695 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND THE REASON WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH BACTEREMIA AND VEGETATION ON THE RV LEAD.

  Patient problems: Bacteremia; Medical device site infection; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24568821 ↗
• MalfunctionFeb 23, 2026Premature Discharge of Battery

  IT WAS 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 24422424 ↗
• InjuryFeb 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VE NTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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 24421156 ↗
• InjuryFeb 13, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IN ADDITION, THE RV LEAD EXHIBITED OVERSENSING, UNDERSENSING AND T-WAVE OVERSENSING (TWOS). IT WAS ALSO REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR VENTRICULAR FIBRILLATION (VF) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PATIENT WAS HOSPITALIZED AND THE ICD WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24333490 ↗
• MalfunctionFeb 5, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE INAPPROPRIATELY DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT)-MONITOR EVENT. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE. THE ICD AND RV LEAD 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 24273461 ↗
• InjuryFeb 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF) EPISODES THAT WERE ACTUALLY FAST CONDUCTED 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 24260661 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE PASSED OUT AND GOT SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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); Syncope/Fainting

  MAUDE report 24260248 ↗
• InjuryFeb 4, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT). THE ICD DETECTED THE EPISODES AS NON-SUSTAINED VT. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24258172 ↗
• InjuryJan 14, 2026Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS CONFIRMED THAT AT THE TIME OF THE EPISODES, THE PATIENT WAS UNDERGOING BREAST RECONSTRUCTION SURGERY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE SUGGESTIVE OF ELECTROMAGNETIC INTERFERENCE (EMI). THE NOISE WAS CONSISTENT WITH THE USE OF CAUTERY. ADDITIONALLY, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO THE NOISE. 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 24069114 ↗
• InjuryNov 25, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY TWENTY-ONE TIMES FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT WAS DEEMED BY THE PHYSICIAN AS INAPPROPRIATE FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PHYSICIAN NOTED THAT A MAGNET WAS APPLIED TO THE DEVICE TO INTERRUPT THE SHOCKS. THE ICD WAS LATER EXPLANTED AND REPLACED DUE TO REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23652934 ↗
• InjuryNov 25, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED 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 23644597 ↗
• MalfunctionNov 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A LOWER THAN 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 23618464 ↗
• InjuryNov 12, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 23534925 ↗
• MalfunctionNov 7, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NON-PHYSIOLOGIC NOISE AND A HIGH RATE NON-SUSTAINED EPISODE CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE. THERE WAS A SINGLE NOISE EPISODE ON A SINGLE DAY WITH NO OTHER RELATED EPISODES. THE PATIENT HAD A HISTORY OF BEING AROUND TREE CUTTING EQUIPMENT. 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 23500767 ↗