Evera™ XT DR DDBB1D4 (UDI 00643169530270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169530270), received between Jun 19, 2017 and Aug 6, 2026 — classified as 1 death, 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) detected an episode of Ventricular Fibrillation (VF) that may have been Atrial arrhythmia with Rapid Ventricular Response (RVR) versus true VF and was treated with Antitachycardia Pacing (ATP) and shocks. 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 50161462 ↗
• InjuryJul 29, 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 shock for Supra Ventricular Tachycardia (SVT) that was detected in the Ventricular Tachycardia (VT) zone. Eleven days later, the ICD del ivered inappropriate ATP and shock for sinus tachycardia detected in the Ventricular Fibrillation (VF) zone. 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 50074874 ↗
• InjuryNov 17, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/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 23575329 ↗
• MalfunctionJun 19, 2024Battery Problem; Inappropriate or Unexpected Reset; Battery Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A WEEK AFTER THE PATIENT WAS IN A CAR ACCIDENT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A PARTIAL POWER ON RESET (POR) WITHOUT DIAGNOSTICS RETAINED. IT WAS ALSO NOTED THAT THE BATTERY HAD SEVERAL UNEXPLAINED DIPS/UNPREDICTABLE BEHAVIORS. 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 19568667 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS POSSIBLY INFECTED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18841596 ↗
• InjuryOct 27, 2022Adverse 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15679932 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12468134 ↗
• MalfunctionAug 18, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY SEEMED TO BE DEPLETING MORE RAPIDLY THAN EXPECTED. 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 12336344 ↗
• InjuryJan 13, 2021Adverse 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 INFECTION THAT WAS INDICATED TO BE SEPSIS. THE PATIENT WAS SENT HOME WITH A LIFEVEST. THE PLAN IS TO IMPLANT A NEW SYSTEM ONCE THE SEPSIS IS RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 11163597 ↗
• InjuryJun 5, 2020Migration or Expulsion of Device; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Migration or Expulsion of Device; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT UNDERGOING AN ABLATION AND AFTERWARDS, STARTED RECEIVING SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT MENTIONS BEING ABLE TO FEEL THE LEAD WIRES. THE PATIENT BELIEVES THAT THE PATIENT HAS AN ICD THAT IS LETTING OFF GAS. THE PATIENT MENTIONS HAVING LOW HEART RATES IN THE 40S WITH THE DEVICE BEING SET AT 60 BEATS PER MINUTE. THE PATIENT MENTIONS THE ICD PROTRUDING WAY UP OVER THE SKIN. FOLLOW UPS WITH THE PATIENT¿S HEALTHCARE PROVIDERS WERE TO NOAVAIL. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 10126212 ↗
• InjuryMar 26, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 9882830 ↗
• InjuryFeb 12, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A POSSIBLE INAPPROPRIATE SHOCK DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE UNDERSENSING ON STORED ELECTROGRAMS (EGM). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 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 9699247 ↗
• InjuryDec 6, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 9431427 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 8840555 ↗
• InjuryMay 31, 2019Adverse 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 AND LATER REPLACED DUE TO AN INFECTION OF BACTERIUM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8658923 ↗
• InjuryApr 3, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUSPECTED AF (ATRIAL FIBRILLATION) WITH RVR (RAPID VENTRICULAR RESPONSE). IT WAS NOTED THAT THERE WAS ONE TREATED VT (VENTRICULAR TACHYCARDIA) AND IT WAS NOTED THAT THERE WAS ATRIAL ARRHYTHMIA IN PROGRESS AT THE TIME OF THERAPY OF WHICH THE SHOCK APPEARS TO HAVE CONVERTED THE PATIENT FROM ATRIAL ARRHYTHMIA. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479929 ↗
• MalfunctionOct 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THREE WEEKS AGO THE PATIENT FELT A JOLT AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. PATIENT WAS RELEASED AND THEN TWO WEEKS LATER PATIENT¿S SPOUSE STATED THE PATIENT WAS IN AFIB (ATRIAL FIBRILLATION). THEN FOR ABOUT TEN DAYS A PATIENT ALERT HAS BEEN GOING OFF. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 7951584 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED A GRAY BATTERY BAR UPON INTERROGATION. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7461866 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) HAD A GRAY BATTERY BAR. THERE WAS NO PATIENT I NVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7460624 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A 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 7459428 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 7459041 ↗
• InjuryApr 10, 2018Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIZZINESS AND PALPITATIONS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED LOSS OF PACING DUE TO THE RIGHT VENTRICULAR (RV) LEAD EXHIBITING T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPROGRAMMED BUT TWOS WAS STILL BEING OBSERVED. FURTHER REPROGRAMMING TOOK PLACE TO RESOLVE THE ISSUE AND THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Palpitations

  MAUDE report 7415296 ↗
• MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PRIOR TO IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATED A ¿GRAY BAR¿ INDICATING THAT THE BATTERY VOLTAGE IS AT A LEVEL THAT IS NOT ACCEPTABLE FOR IMPLANT. THE ICD WAS REMOVED FROM SERVICE. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7414498 ↗
• MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE INTERROGATED THE DEVICE PRIOR TO USE, IT WAS NOTICED TO HAVE A GRAY BATTERY LONGEVITY STATUS BAR. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7413640 ↗
• MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INITIALLY INTERROGATED AND THE DEVICE SHOWED A GREY BAR FOR BATTERY LONGEVITY. THE FIELD REPRESENTATIVE RECHECKED THE DEVICE AFTER STORING IT IN A WARM ENVIRONMENT FOR OVER SEVEN DAYS AND THE GREY BAR CONTINUED TO DISPLAY. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7411891 ↗