Evera™ XT DR DDBB1D1 (UDI 00643169018099)Recalls & reported problems

Summary

The FDA's MAUDE database contains 740 adverse event reports that list this exact device (DI 00643169018099), received between Feb 9, 2016 and Sep 10, 2026 — classified as 22 deaths, 523 injuries, 195 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (207 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 740 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718260 ↗
• MalfunctionJun 22, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED AN EPISODE OF ANOTHER 1:1 SUPRA VENTRICULAR TACHYCARDIA (SVT) AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. 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 25580882 ↗
• MalfunctionMar 16, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A LOSS OF TELEMETRY.  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 24608994 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INITIALLY A SUSPECTED INSULATION BREACH, POSSIBLY FROM CLAVICLE CRUSH, ON THE RIGHT VENTRICULAR (RV) LEAD, AS THE PATIENT EXPERIENCED PAIN, DISCOMFORT IN THE CHEST AND NECK, THROAT PRESSURE, AND STIMULATION IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET AREA IN RESPONSE TO RV-ONLY PACING. A PRIOR SPIKE IN AND RECENT INCREASE IN CAPTURE THRESHOLDS WAS NOTED ON THE RV LEAD. THE PATIENT WAS NOT SYMPTOMATIC WHEN PROGRAMMED TO DUAL CHAMBER PACING. WITH FURTHER TESTING, IT WAS DETERMINED THAT THE PATIENT WAS SYMPTOMATIC AND EXPERIENCING PACEMAKER SYNDROME WITH VENTRICLE-ONLY PACING WHICH HAD BEEN TRIGGERED WHEN THE ICD HAD REACHED THE RECOMMENDED REPLACEMENT TIME (RRT). THE ELECTROPHYSIOLOGIST CONCLUDED THERE WAS NO INSULATION ISSUE. THE ICD AND RV LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 24345551 ↗
• MalfunctionFeb 16, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE SENSED ON THE ATRIAL CHANNEL OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD ON STORED FAST VENTRICULAR TACHYCARDIA (FVT) EPISODES. THE DEVICE AND 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 24343340 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24135352 ↗
• DeathJan 16, 2026Failure to Charge

  IT WAS REPORTED THAT THERE WAS OVERSENSING, UNDERSENSING, AND A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS ON THE RIGHT VENTRICULAR (RV) LEAD. A CHARGE CIRCUIT TIME OUT OCCURRED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DURING A VENTRICULAR FIBRILLATION (VF) STORM. IT WAS ALSO NOTED THERE WAS NOISE ON THE RIGHT ATRIAL (RA) LEAD. THE PATIENT PASSED AWAY THREE DAYS LATER.

  Patient problems: Insufficient Information

  MAUDE report 24093814 ↗
• InjuryDec 17, 2025Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING A PHYSICAL ALTERCATION AND A FALL THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT NOTED DISCOMFORT AND A JERKING FEELING IN THEIR CHEST. UPON REVIEW OF THE EPISODES, IT WAS ALSO NOTED THAT SHORT CIRCUIT PROTECTION (SCP) OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY FOR ALL SIX SHOCKS PROVIDED. IT COULD NOT BE DETERMINED WHETHER THE ICD OR RIGHT VENTRICULAR (RV) LEAD WAS RESPONSIBLE FOR THE SCP. OUT OF RANGE (OOR) LOW IMPEDANCE WAS ALSO OBSERVED ON THE RV LEAD DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) COILS. THE RV LEAD REMAINS IN USE AND THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23828670 ↗
• MalfunctionDec 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ¿IS NOT WORKING AND IS OUT OF CHARGE.¿ THE PATIENT ALSO NOTED THAT THEY HAD ATRIAL FIBRILLATION (AF) AND ¿A LOT OF PROBLEMS.¿ THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23684005 ↗
• DeathNov 25, 2025Premature Discharge of Battery; Premature Discharge of Battery

  A LAWSUIT ALLEGED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS FORCED TO LIVE IN A STATE OF FEAR AND ANXIETY WITH A L IFE-SUSTAINING DEVICE THE PATIENT KNEW WAS FAILING. THE PATIENT WAS ALLEGED TO HAVE SUSTAINED SEVERE AND CONSCIOUS PAIN, SUFFERING, DISABILITY, AND LOSS OF ENJOYMENT OF LIFE IN THE MONTHS LEADING UP TO THEIR DEATH. IT WAS ALLEGED THAT DEVICE INTERROGATIONS AND OFFICE VISITS REVEALED AN ALARMING DECLINE IN ICD BATTERY LIFE IN THE SETTING OF A SIGNIFICANT INCREASE IN DANGEROUS CARDIAC EVENTS, AND THE PATIENT LATER COMPLAINED THE "PACEMAKER ALARM HAS BEEN GOING OFF AND ON FOR ABOUT 1 MONTH" AND THEY WERE HEARING A "BEEPING SOUND". A DEVICE INTERROGATION FOUR MONTHS LATER REVEALED THAT THE ICD'S BATTERY LONGEVITY HAD FALLEN TO ONLY EIGHT MONTHS AND THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS. A SUBSEQUENT DEVICE INTERROGATION SIX MONTHS LATER SHOWED THE ICD'S BATTERY LIFE HAD FURTHER DWINDLED TO ONLY THREE MONTHS. THE LAWSUIT FURTHER ALLEGED THE DEFECTIVE AND FAILING ICD, WITH A BATTERY THAT FAILED PREMATURELY AND DID NOT PROVIDE ADEQUATE WARNING OF ITS END-OF-LIFE STATUS, WAS NOT REPLACED TIMELY, AND AS A RESULT THE PATIENT SU

  Patient problems: Anxiety; Pain

  MAUDE report 23649299 ↗
• InjuryNov 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF)EVENT(S) AT TIMES. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF INAPPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE RA LEAD AND ICD 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 23570874 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Low impedance; Mechanical Problem; Low impedance

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD, IT WAS NOTED THAT ATRIAL BIPOLAR IMPEDANCE WAS INDICATED AS LOW AND IN CLINIC TESTING SHOW IN RANGE MEASUREMENTS. IT WAS NOTED THAT THE ATRIAL LEAD LOW IMPEDANCE MEASUREMENT WAS AN ERROR, NOT A TRUE MEASUREMENT. IT WAS NOTED THAT THERE WAS AN EXPECTED WEEKLY ATRIAL LEAD IMPEDANCE MEASUREMENT, BUT A HIGH VOLTAGE IMPEDANCE MEASUREMENT OCCURRED. IT WAS SUSPECTED THAT AFTER IMPLANT, THE RA LEAD EITHER WAS NOT USED OR COMPLETELY DISLODGED FROM THE ICD HEADER. ADDITIONALLY, THE PATIENT REPORTED FEELING ICD DEVICE VIBRATION IN THE AFTERNOONS ALONG WITH SYMPTOMATIC WITH RIGHT VENTRICULAR PACING THAT APPEARED TO CORRELATE WITH RIGHT VENTRICULAR CAPTURE MANAGEMENT. THE ICD AND RA LEAD 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 23556097 ↗
• MalfunctionOct 15, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING (60HZ NOISE). 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 23304040 ↗
• MalfunctionOct 15, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING (60HZ NOISE).  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 23303115 ↗
• InjurySep 15, 2025Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). 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 23057729 ↗
• InjurySep 8, 2025Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) 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 22998842 ↗
• MalfunctionSep 8, 2025Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE REMOTE MONITOR HAD NO TELEMETRY AFTER THE PATIENT WAS ENROLLED IN CARELINK AT A NEW CLINIC. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A POTENTIAL BATTERY ISSUE. TROUBLESHOOTING STEPS INCLUDED VERIFYING THE FIRMWARE UPDATE IN THE FIRMWARE DISTRIBUTION NETWORK, ATTEMPTING MANUAL TRANSMISSION WITH NO TELEMETRY OR PROGRESS BAR DISPLAYED, ADJUSTING THE READER POSITION, POWER CYCLING THE MONITOR, REMOVING A NEARBY IPAD, AND PLACING A WASHCLOTH. THE PATIENT WAS REFERRED TO THE CLINIC, AND IT WAS CONFIRMED THAT THE CARELINK DEVICE SERIAL NUMBER AND ICD MODEL NAME MATCHED. IT WAS NOTED THAT THERE HAS BEEN NO RECORD OF A SUCCESSFUL TRANSMISSION FROM THE ICD. 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 22993718 ↗
• InjuryAug 29, 2025Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PATIENT PASSED OUT AND FELL DURING THE EPISODE, HURTING THEIR LEFT FOOT. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Damage to Ligament(s); Fall; Syncope/Fainting; Tachycardia

  MAUDE report 22923510 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER CLARIFIED THAT THERE WERE NO PRODUCT PERFORMANCE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921171 ↗
• InjuryAug 26, 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 FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899013 ↗
• InjuryJun 27, 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 ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). A COUPLE OF WEEKS LATER, THE ICD DELIVERED ATP AND SHOCKS AGAIN FOR AF WITH RVR THAT DETECTED 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 22350268 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRAUMA AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SITE, A WOUND DEVELOPED AND THE DEVICE ERODED. THE DEVICE WAS EXPLANTED AND THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 22346920 ↗
• InjuryJun 26, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR FIBRILLATION (VF). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE ICD AND RV 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 22340038 ↗
• InjuryJun 25, 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 DUE TO A POTENTIAL PRODUCT PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331117 ↗
• InjuryJun 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309316 ↗