Evera™ XT DR DDBB1D1 (UDI 00643169530263)Recalls & reported problems

Summary

The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 00643169530263), received between Dec 9, 2016 and Sep 16, 2026 — classified as 7 deaths, 177 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (75 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 268 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Battery Problem

  It was reported that there was an inquiry made on advisory for potential shortened Recommended Replacement Time (RRT) to End of Service (EOS). 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 50793081 ↗
• MalfunctionAug 6, 2026Electromagnetic Interference; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158269 ↗
• InjuryJun 9, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THERE WAS ATRIAL UNDERSENSING OBSERVED ON STORED EPISODES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25446150 ↗
• InjuryMay 21, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE ARRHYTHMIA AS VENTRICULAR FIBRILLATION (VF). THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25249610 ↗
• InjuryApr 2, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR TACHYCARDIA (VT) AND 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 24769422 ↗
• InjuryMar 10, 2026Defibrillation/Stimulation Problem; Battery Problem; Inappropriate or Unexpected Reset; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SHORT CIRCUIT PROTECTION (SCP) DURING HIGH VOLTAGE THERAPY RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED. IT COULD NOT BE DETERMINED WHICH PART OF THE SYSTEM CAUSED THE SCP THOUGH THERE WERE NO FURTHER RIGHT VENTRICULAR (RV) LEAD ISSUES OBSERVED. IT WAS ALSO NOTED THAT THERE WAS A GRAY BAR RE-INITIALIZING MESSAGE FOR BATTERY LONGEVITY AND UPON FURTHER REVIEW IT WAS DISCOVERED THAT THERE WAS A SIGNIFICANT BATTERY VOLTAGE DROP ON THE SAME DAY. IT WAS ALSO NOTED THAT THE ICD PREVIOUSLY EXHIBITED A PARTIAL ELECTRICAL RESET. THE ICD AND RV LEAD WERE EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562249 ↗
• MalfunctionFeb 17, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THE "HEART RATE WENT FROM 60 UP TO 130 AND I WAS NOT DOING ANYTHING, I WAS JUST SITTING IN MY CHAIR, I WASN'T STRESSED OUT ABOUT NOTHING. NOW YESTERDAY AND TODAY I AM FEELING WIPED OUT. I FEEL LIKE MY DEVICE IS MALFUNCTIONING. I HAVE HAD DEVICES FOR MANY YEARS AND THIS IS FEELING DIFFERENT TO ME." THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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; Tachycardia

  MAUDE report 24366648 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED AND REPLACED DUE TO EROSION. THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO THE LEAD BREAKING DURING EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24323373 ↗
• MalfunctionDec 19, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE INTERMITTENT OVERSENSING AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE. THE RA LEAD AND CRT-D 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 23855867 ↗
• MalfunctionDec 19, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. ELECTROMAGNETIC INTERFERENCE (EMI) AND NOISE WAS ALSO OB SERVED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE 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 23849816 ↗
• MalfunctionNov 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT WORKING. 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 23576716 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PREVIOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD BEEN EXPLANTED DUE TO METHICILLI N-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23075897 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISLODGED AND 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 22902762 ↗
• MalfunctionAug 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS "NOT FUNCTIONING". 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 22844090 ↗
• InjuryAug 8, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES ON THE RIGHT VENTRICULAR (RV) CHANNEL AND DELIVERED SHOCKS DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) FROM FAULTY WIRING IN A POOL. A YEAR LATER, NOISE WAS NOTED ON BOTH THE PACE/SENSE RV AND RIGHT ATRIAL (RA) LEADS FROM EMI. THE RV LEAD TRIGGERED SEVERAL LIAS AND A FEW YEARS LATER, THE LEADS CONTINUED TO DISPLAY NOISE ON STORED EPISODES. IN-CLINIC TESTING SHOWED ADDITIONAL RA OVERSENSING OF NOISE AND RV LEAD NOISE WITH PATIENT ARM MANEUVERS. THE ICD AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22755585 ↗
• InjuryJul 18, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS A POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD RESULTING INAPPROPRIATE ATRIAL PACING AND FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE DEVICE AND LEAD 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 22542172 ↗
• InjuryJul 17, 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 POSSIBLE INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) WHICH WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). 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 22536578 ↗
• 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) PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THE ICD SYSTEM WAS EXPLANTED . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22143169 ↗
• InjuryMay 30, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR HEART RATES IN THE 20-30 BEATS PER MINUTE (BPM) RANGE, HOWEVER, THE DEVICE LOWER RATE WAS PROGRAMMED TO 40 BPM. THE FOLLOWING DAY THE RA LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH PACING IMPEDANCE. IT WAS NOTED THAT THE DEVICE WAS REPROGRAMMED AND THE LOWER RATE WAS INCREASED, AND REPROGRAMMING WAS DONE FOR THE RA LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22117393 ↗
• InjuryMay 1, 2025Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING ELECTROCAUTERY, THE MAGNET WAS NOT OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND SUBSEQUENTLY, THE PATIENT RECEIVED AN INAPPROPRIATE 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 21943945 ↗
• InjuryApr 29, 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) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR OTHER ONE TO ONE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED  UNDERSENSING. THE DEVICE AND LEAD 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 21930793 ↗
• MalfunctionApr 21, 2025Battery Problem; Battery Problem

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876691 ↗
• InjuryMar 4, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED, AND THAT THE LAST REMOTE TRANSMISSION SHOWED TWO YEARS BATTERY LIFE REMAINING. 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 21515590 ↗
• MalfunctionFeb 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATIONDURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293717 ↗
• MalfunctionJan 31, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) RHYTHM THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 21284069 ↗