Evera™ XT VR DVBB1D1 (UDI 00643169017955)Recalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 00643169017955), received between Dec 9, 2015 and Sep 29, 2026 — classified as 9 deaths, 273 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (88 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 359 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  Patient problems: Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 50931672 ↗
• InjurySep 17, 2026Electrical /Electronic Property Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) possibly delivered inappropriate shocks and Anti-Tachycardia Pacing (ATP) for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR). The ICD detected the episodes as Fast Ventricular Tachycardia (FVT). The ICD also alerted due to the charge circuit being inactive. 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 50803436 ↗
• InjurySep 11, 2026Delayed Charge Time

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited long charge times and a charge circuit timeout, resulting in a delay of therapy for the patient's Ventricular Fibrillation (VF) episode. The patient remained in Ventricular Fibrillation (VF). The device was explanted and replaced.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50732678 ↗
• InjurySep 9, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697992 ↗
• MalfunctionJun 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT NOTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS "NOT FIRING CORRECTLY" AND IS EXPERIENCING A "BURNING" SENSATION AT DEVICE SITE. THE 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 25409425 ↗
• InjuryMay 29, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A "MAJOR" STROKE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 25336687 ↗
• MalfunctionMay 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) MISDETECTED AS VENTRICULAR T ACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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; Shock from Patient Lead(s)

  MAUDE report 25257375 ↗
• InjuryMay 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE HOSPITALIZED FOR A SMALL STROKE FOR TWO DAYS. THE PATIENT NOTED THAT AT NIGHT, THEIR HEART MONITOR WOULD "ALARM" THAT THEIR HEART RATE WAS LOW AND IN THE THIRTIES. THE PATIENT NOTED THAT TWO WEEKS PRIOR TO THEIR HOSPITAL STAY, THEY NOTICED THAT THEIR HEART RATE WAS LOW AS WELL.  ADDITIONALLY, THE PATIENT MENTIONED THAT APPROXIMATELY TWO MONTHS PRIOR TO THE CALL, THEY HAD BRADYCARDIA AGAIN AFTER ABOUT TEN YEARS WITHOUT IT. THE PATIENT WAS CONCERNED WITH THEIR HEART RATE DROPPING LOW AT NIGHT AND WHEN THEY REST, STATING "IT COULD BE PROBLEMATIC". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Transient Ischemic Attack

  MAUDE report 25086435 ↗
• InjuryMay 4, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT ABOUT FIVE YEARS AGO THERE WAS TONING FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE AFTER A SURGERY THAT THE DOCTOR "DID NOT PUT THE MAGNET OVER THE DEVICE" AND THE DEVICE WAS INTERFERED WITH." THE PATIENT INDICATED "POSSIBLY RECEIVED A SHOCK." 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 25072232 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS AND VEGETATION WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800945 ↗
• MalfunctionMar 31, 2026Electromagnetic Interference; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), ELECTROMAGNETIC INTERFERENCE (EMI) OCCURRED WHICH ALSO TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE ICD WAS SUBSEQUENTLY EXPLANTED AND REPLACED APPROXIMATELY THREE YEARS LATER, HOWEVER, THIS WAS DUE TO MEDICAL JUDGEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745991 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FEVER AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Fever

  MAUDE report 24670742 ↗
• InjuryMar 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD WAS ELECTIVELY REPLACED DUE TO A SYSTEM UPGRADE, AND THERE WAS NO PERFORMANCE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669142 ↗
• InjuryMar 20, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A MINI STROKE APPROXIMATELY TWO MONTHS AGO. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 24649738 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS THE KNEE AND THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24618545 ↗
• InjuryFeb 19, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT)/ATRIAL FIBRILLATION (AF) MISDETECTED 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 24393755 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT HIGH VOLTAGE THERAPY WAS APPROPRIATE AND THE ICD WAS REPLACED DUE TO A SYSTEM UPGRADE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24335773 ↗
• InjuryFeb 13, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS. GIVEN THE PATIENT HAD A SINGLE CHAMBER ICD, IT WAS DIFFICULT TO ASSESS IF THE SHOCKS WERE DUE TO ATRIAL FIBRILLATION (AF) OR ATRIAL FLUTTER (AFL) WITH RAPID VENTRICULAR RESPONSE (RVR), VERSUS A TRUE VENTRICULAR ARRHYTHMIA. THE DEVICE HAD DETECTED THE ARRHYTHMIA AS VENTRICULAR FIBRILLATION (VF). THE PHYSICIAN CHOSE TO REMOVE THE ICD AND UPGRADE THE PATIENT TO A BIVENTRICULAR ICD SYSTEM; THE PATIENT ALSO UNDERWENT ATRIOVENTRICULAR (AV) NODAL ABLATION. A POST-PROCEDURE DIAGNOSIS INDICATED THAT THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; Shock from Patient Lead(s)

  MAUDE report 24332815 ↗
• InjuryFeb 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE THERAPIES DELIVERED WERE APPROPRIATE PER THE PROGRAMMED THERAPY ZONES. HOWEVER, THE ARRYTHMIA DID NOT APPEAR TO BE A TRUE VENTRICULAR ARRYTHMIA. DUE TO THE LOW PROGRAMMED THERAPY ZONES THE ICD DELIVERED MULTIPLE HIGH VOLTAGE THERAPIES WHICH RESULTED IN THE BATTERY DEPLETING. THE ICD WAS REPROGRAMMED TO CHANGE THE THERAPY ZONES.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24284328 ↗
• InjuryFeb 6, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED.

  Patient problems: Tachycardia

  MAUDE report 24277815 ↗
• InjuryFeb 4, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A MAGNET WAS SWIPED OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BUT THE MAGNET WAS NOT PLACED OVER THE DEVICE FOR THE DURATION OF THE SURGERY. THE PATIENT WAS SHOCKED TWICE DURING THE SURGERY AND SINCE THEN ALERTS WERE GOING OFF TWICE A DAY. 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 24262136 ↗
• MalfunctionJan 28, 2026Mechanical Problem; Defibrillation/Stimulation 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 TRIGGERED ALERTS FOR UNDEFINED HIGH RV DEFIBRILLATION COIL IMPEDANCES AND UNDEFINED HIGH RV PACING IMPEDANCES. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED OVERSENSING RESULTING IN FALSE EPISODE DETECTIONS. IT WAS ALSO REPORTED THAT SHOCKS WERE DELIVERED WITH OUTPUT LESS THAN THE PROGRAMMED OUTPUT. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT AN RV LEAD FRACTURE OR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONNECTION ISSUE WAS MOST LIKELY IMPACTING THE THERAPY DELIVERY. 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 24202000 ↗
• InjuryDec 19, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT "3 WEEKS AGO HE WENT INTO VENTRICULAR TACHYCARDIA (VT), IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT GO OFF. PADDLED A COUPLE OF TIMES. MY QUESTION IS WHY THE ICD DID NOT WORK?" THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN SPECULATED THAT THE DEVICE WAS "POSSIBLY SET TOO HIGH, PICKED UP FLUTTER NOT VT". THE DEVICE WAS EXPLANTED AND REPLACED APPROXIMATELY FOUR DAYS LATER DUE TO THE PATIENT'S INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23851857 ↗
• InjuryDec 19, 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 VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD AND POCKET INFECTION. TEMPORARY LEADS WERE USED, THEN A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23851469 ↗
• InjuryDec 15, 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) AND COMPETITOR LEAD WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23802215 ↗