Evera™ XT DR DDBB1D1 (UDI 00643169929111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00643169929111), received between Oct 6, 2017 and Sep 16, 2026 — classified as 5 deaths, 45 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (28 reports).

1 FDA recall record name this device's identifier.

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. 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796577 ↗
• InjurySep 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50740763 ↗
• InjuryJun 30, 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 SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE 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 25673734 ↗
• InjuryDec 29, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT AN ALERT TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS DURING THE PATIENT'S SHOULDER SURGERY. THE PATIENT RECEIVED SEVERAL INAPPROPRIATE HIGH VOLTAGE THERAPIES FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO OVERSENSING WAS NOTED OUTSIDE THE SURGICAL PROCEDURE TIMEFRAME. 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 23909105 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VEGETATION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23769972 ↗
• InjuryOct 15, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PACEMAKER MEDIATED TACHYCARDIA (PMT) WHERE THE LONGEST INTERVAL WAS 340 MS WHEN PROGRAMMED VVI WITH RETROGRADE CONDUCTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23291690 ↗
• InjurySep 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 POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT) AND FAST VENTRICULAR TACHYCARDIA (FVT). THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN INAPPROPRIATE PACING. THE ICD AND 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 23041735 ↗
• InjuryAug 6, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS FURTHER REPORTED THAT AT THE TIME OF A PLANNED LEAD EXTRACTION PROCEDURE, IT WAS SUSPECTED THAT THERE WAS AN INFECTION, SO THE WHOLE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 22728496 ↗
• InjuryJul 14, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS REPROGRAMMED AND REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500812 ↗
• InjuryJan 21, 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 THERAPY DURING SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 21197070 ↗
• InjuryJan 8, 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 THERAPY FOR RAPID VENTRICULAR RESPONSE (RVR). THERE WAS AN ATRIAL ARRHYTHMIA IN PROGRESS AT TIME OF THERAPY. THE DEVICE DETECTED THE EPISODE AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 21103145 ↗
• InjuryDec 2, 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) SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 20820412 ↗
• MalfunctionNov 8, 2024Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT OVERSENSING, NOISE AND A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) WERE OBSERVED DUE TO ELECTROMAGNETIC INTERFERENCE WHILE THE PATIENT WAS SWIMMING. 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 20638210 ↗
• DeathOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S WIFE THAT THEIR SPOUSE "WENT TO THE HOSPITAL, THEY SHUT OFF THE PACEMAKER, HAD TROUBLE GETTING THE HEART RATE UP, THEN PLACED ON LIFE SUPPORT AND THEN DIED." FOLLOW UP WAS CONDUCTED WITH THE PATIENT'S FUNERAL HOME AND THE CAUSE OF DEATH WAS REPORTED AS CARDIOGENIC SHOCK. THE DEVICE REMAINS IN THE PATIENT. THE PATIENT IS DECEASED.

  Patient problems: Cardiogenic Shock

  MAUDE report 20347107 ↗
• MalfunctionJul 9, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR TWO EPISODES THAT WERE SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODES AS VENTRICULAR TACHYCARDIA (VT). 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 19705787 ↗
• MalfunctionJul 1, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED DUE TO FAST RATES, AND INCONSISTENT PACING. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC. 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 19644791 ↗
• MalfunctionMay 3, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) AND DELIVERED SEVERAL ANTI-TACHYCARDIA PACING SEQUENCES. IT WAS SUSPECTED THAT THERE WAS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AT THE TIME OF THE EVENT, MEANING THAT THE ATP WAS POTENTIALLY INAPPROPRIATE. 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 19239108 ↗
• InjuryApr 1, 2024Pacing 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) INAPPROPRIATELY DELIVERED A SHOCK AND ANTI-TACHYCARDIA PACING FOR AN EPISODE OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD MISCLASSIFIED 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 19014990 ↗
• MalfunctionMar 28, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHEN THE DEVICE MISCLASSIFIED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE ICD AND RA 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 19000900 ↗
• InjuryDec 27, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS PROVIDED INAPPROPRIATE THERAPY  AND WAS FOUND ON THE FLOOR. THE PATIENT EXPERIENCED SYNCOPE AND PRESENTED TO THE EMERGENCY DEPARTMENT. A REMOTE TRANSMISSION SHOWED THAT THE RIGHT ATRIAL (RA) LEAD LEAD WAS INTERMITTENTLY UNDERSENSING. THE LEAD AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 18401509 ↗
• InjuryNov 28, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR  RECEIVING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK. THE PATIENT RECEIVED INAPPROPRIATELY THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) INSTEAD OF VENTRICULAR TACHYCARDIA / 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); Tachycardia; Ventricular Fibrillation

  MAUDE report 18221417 ↗
• InjuryMar 17, 2023Inappropriate/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 THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE DEVICE AND 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 16564840 ↗
• InjuryMar 1, 2023Adverse 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16459680 ↗
• InjuryNov 16, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING A SUPRA VENTRICULAR TACHYCARDIA (SVT) ARRHYTHMIA AS A VENTRICULAR FIBRILLATION (VF) EPISODE. THE DEVICE WITHHELD THERAPY FOR THE SVT BUT HIGH RATE TIMEOUT CRITERIA DELIVERED VF THERAPY FOR THE SVT. 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 15810607 ↗
• DeathOct 12, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE, THAT THE PATIENT EXPERIENCED CARDIAC ARREST THE NIGHT PRIOR TO PASSING AWAY. THE EMERGENCY MEDICAL TEAM (EMT) ATTEMPTED TO ¿BRING THE PATIENT¿S HEART BACK¿. THE PATIENT WAS THEN BROUGHT TO THE EMERGENCY DEPARTMENT, AND THE PATIENT¿S FAMILY WAS ASKED IF THE ¿LEADS WERE STILL GOOD BECAUSE IT DIDN¿T SEEM LIKE THEY WERE DEFIBRILLATING THE HEART AT THE TIME OF CARDIAC ARREST¿. THE PATIENT WAS BEING TREATED AT A HEART FAILURE CLINIC. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. THE PATIENT IS DECEASED.

  Patient problems: Cardiac Arrest

  MAUDE report 15588602 ↗