Evera™ XT DR DDBB1D4 (UDI 00643169018082)Recalls & reported problems

Summary

The FDA's MAUDE database contains 640 adverse event reports that list this exact device (DI 00643169018082), received between Jun 10, 2014 and Sep 28, 2026 — classified as 21 deaths, 467 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (182 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 640 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915136 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that one day post implant of the Implantable Cardioverter Defibrillator (ICD) the patient had a stroke which damaged the patient's fontal lobe. The device was explanted and replaced approximately eleven years later. The Right Atrial (RA) lead and Right Ventricular (RV) lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Stroke/CVA

  MAUDE report 50012459 ↗
• InjuryMay 27, 2026Pacing 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 TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE 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 25311085 ↗
• InjuryMay 11, 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE PATIENT REPORTEDLY EXPERIENCED PALPITATIONS. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations; Shock from Patient Lead(s)

  MAUDE report 25139006 ↗
• DeathApr 3, 2026Defibrillation/Stimulation Problem; Delayed Charge Time

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED THAT MORE THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. THE PATIENT'S VENTRICULAR FIBRILLATION (VF) EPISODE CONTINUED HOWEVER THE DEVICE WAS UNABLE TO DELIVER FURTHER HIGH VOLTAGE THERAPY DUE TO A CHARGE CIRCUIT TIME OUT AND EXTERNAL DEFIBRILLATION WAS NEEDED TO TERMINATE THE EPISODE. THE PATIENT THEN EXPERIENCED ADDITIONAL VF EPISODES WHICH ALSO REQUIRED EXTERNAL DEFIBRILLATION. THE PATIENT SUBSEQUENTLY PASSED AWAY.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24777937 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 24550037 ↗
• InjuryFeb 24, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE ¿NOT WORKING¿ AND WERE SUBSEQUENTLY 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 24429735 ↗
• InjuryFeb 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND MULTIPLE SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD ALSO DETECTED ATRIAL FIBRILLATION (AF) SUSPECTED TO BE ATRIAL FLUTTER. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PATIENT WAS ADMINISTERED MEDICATION FOR RATE CONTROL.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24269293 ↗
• MalfunctionNov 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT SUSPECTED T-WAVE OVERSENSING (TWOS) WAS OBSERVED DURING EVERY IMPEDANCE TESTING AND ONLY LASTING FOR A FEW BEATS. 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 23523281 ↗
• InjuryOct 30, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF) EPISODES THAT WERE SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD WAS LATER EXPLANTED AND REPLACED DUE TO RECOMMENDED REPLACEMENT TIME (RRT). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23427829 ↗
• InjuryOct 24, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED RECOMMENDED REPLACEMENT TIME (RRT) STATUS. THE DEVICE BATTERY EXPERIENCED A LONGER CHARGE TIME THAN EXPECTED. 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 23382497 ↗
• InjurySep 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE, THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE WAS NOTED TO BE WITHIN NORMAL RANGE. WHEN ATTEMPTING TO DISCONNECT THE RV LEAD FROM THE DEVICE, THE SETSCREW COULD NOT BE ENGAGED OR TURNED, REQUIRING THE PHYSICIAN TO FORCEFULLY PULL THE RV LEAD PIN FROM THE ICD HEADER. THE ICD WAS THEN EXPLANTED. WHEN THE CHRONIC RV LEAD WAS CONNECTED TO A NEW ICD, THERE WERE UNSTABLE, HIGH/LOW PACING IMPEDANCES OBSERVED. HOWEVER, WHEN THE RV LEAD WAS TESTED THROUGH THE ANALYZER THE PACING IMPEDANCE WAS FOUND TO BE NORMAL AND STABLE. THE IMPLANTING PHYSICIAN REQUESTED TO CONNECT THE CHRONIC RV LEAD WITH A SECOND NEW ICD DEVICE, BUT SIMILAR PACING IMPEDANCE ISSUES WERE OBSERVED. THE PHYSICIAN SUSPECTED THAT THE RV LEAD HAD BEEN DAMAGED, AND THE CAUSE WAS ATTRIBUTED TO HOW THE LEAD WAS AFFIXED IN THE DEVICE HEADER. A LOW VOLTAGE RV FRACTURE WAS SUSPECTED. THE SECOND ATTEMPTED ICD WAS SUCCESSFULLY IMPLANTED ALONG WITH THE CHRONIC RV LEAD. THE PATIENT WAS HOSPITALIZED FOR ADDITIONAL OBSERVATION AND PLANNING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956076 ↗
• MalfunctionAug 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT HEARD A HIGH LOW TONE TWICE IN ONE DAY AND STATED IT COULD BE A BATTERY CONCERN. 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 22801378 ↗
• MalfunctionJul 7, 2025Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND 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 22414169 ↗
• InjuryJul 3, 2025Failure to Charge; Failure to Charge

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398564 ↗
• InjuryJun 26, 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 SUSPECTED INAPPROPRIATE THERAPY DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED 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 22339775 ↗
• InjuryJun 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241561 ↗
• MalfunctionJun 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY DISPLAYED A DROP IN THE REMAINING 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 22236951 ↗
• InjuryJun 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 POTENTIALLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PATIENT EXPERIENCED SHORTNESS OF BREATH. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Shock from Patient Lead(s)

  MAUDE report 22196311 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION ASSOCIATED WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE SOURCE OF THE INFECTION WAS A SACRAL WOUND. RIGHT VENTRICULAR (RV) LEAD VEGETATION AND POSSIBLE MITRAL VALVE VEGETATION WAS NOTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS, ACUTE RENAL FAILURE ON HEMODIALYSIS, THROMBOCYTOPENIA, AND ATRIAL FIBRILLATION (AF). THE ICD, RV AND RIGHT ATRIAL (RA) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Bacterial Infection; Renal Failure; Sepsis; Thrombocytopenia; Unspecified Infection

  MAUDE report 22158616 ↗
• InjuryApr 30, 2025Pacing 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) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT EXPERIENCED BACK PAIN. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Back pain; Shock from Patient Lead(s)

  MAUDE report 21939410 ↗
• MalfunctionApr 25, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS "DEFECTIVE" AND THAT INAPPROPRIATE PACING WAS DELIVERED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED WHICH RESULTED IN AN INCREASE TO IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AND THE LEAD WAS FRACTURED. THE ICD AND RV 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 21913996 ↗
• InjuryApr 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. 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 21821056 ↗
• MalfunctionMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT AFTER A BLOOD PRESSURE CHECK, ¿EVERYTHING WENT CRAZY AND WACKO. PULSE WAS AT THIRTY-FIVE BEATS PER MINUTE.¿ THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21642510 ↗
• MalfunctionMar 6, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. 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 21536363 ↗