Evera™ S DR DDBC3D1 (UDI 00643169018044)Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00643169018044), received between Dec 9, 2016 and Feb 20, 2026 — classified as 7 deaths, 103 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (26 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 143 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND SEPSIS WAS NOTED.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 24401279 ↗
• InjuryFeb 3, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE FROM AN ITEM PURCHASED BY THE PATIENT AND THE PATIENT WAS SHOCKED SEVERAL TIMES. THE DEVICE 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 24251156 ↗
• InjuryDec 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO DAYS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) A SET SCREW REPOSITIONING PROCEDURE WAS PERFORMED. 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 23821169 ↗
• MalfunctionDec 16, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE THAT RESULTED IN OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL AND MISCLASSIFICATION OF EPISODES. THE ICD WAS EXPLANTED APPROXIMATELY A WEEK LATER DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821077 ↗
• InjuryJul 23, 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 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 22578341 ↗
• InjuryJun 16, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR FIBRILLATION (VF). THE ICD WAS EXPLANTED THREE DAYS LATER DUE TO REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22215148 ↗
• InjuryJun 13, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ANTI-TACHYCARDIA PACING (ATP) THERAPIES WERE DISABLED AFTER THEY CAUSED AN ACCELERATED VENTRICULAR RATE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 22203721 ↗
• InjuryMay 6, 2025Failure to Charge; Pacing Problem; Delayed Charge Time; Device Sensing Problem; Failure to Charge; Pacing Problem; Delayed Charge Time; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE CIRCUIT TIMEOUT. THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE ICD WAS EXPLANTED AND REPLACED. THE RA 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 21972511 ↗
• InjuryMar 27, 2025Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE'S DISCRIMINATOR FEATURE INAPPROPRIATELY INHIBITED OR DELAYED THERAPY DURING AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21707812 ↗
• InjuryJan 29, 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) SYSTEM WAS EXPLANTED DUE TO A BACTEREMIA INFECTION LEADING TO SEPSIS. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS FROM A LAB REPORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 21266791 ↗
• InjuryJan 13, 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 FOR POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE EPISODES AND OTHER ATRIAL TACHYCARDIAS, WHICH WERE DETECTED AS VENTRICULAR TACHYCARDIA (VT)/ 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 21143409 ↗
• InjuryJan 3, 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) SYSTEM WAS EXPLANTED DUE TO INFECTION AND VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 21069418 ↗
• InjuryDec 11, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED WITH ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SHOCKED FOR AN EPISODE VENTRICULAR TACHYCARDIA (VT) BUT THE RHYTHM 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 20904887 ↗
• InjuryNov 12, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A POSSIBLE INAPPROPRIATE SHOCK FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. 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 20668656 ↗
• InjuryAug 13, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DETECTED AN EPISODE AS VENTRICULAR TACHYCARDIA (VT) VERSUS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE DEVICE AND 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 19974633 ↗
• InjuryMar 19, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE LEADING TO INAPPROPRIATE SHOCK. REPROGRAMMING WAS COMPLETED AND 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 18933888 ↗
• MalfunctionJan 23, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PATIENT'S HEART RATE WAS IN THE FORTIES, AND ABNORMAL DEVICE FUNCTION WAS SUSPECTED. A REVIEW BY QUALIFIED PERSONNEL DETERMINED THAT THE DEVICE WAS CURRENTLY FUNCTIONING AS PROGRAMMED. 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 18564446 ↗
• DeathJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT IS DECEASED AND DIED FOLLOWING DEVICE REPLACEMENT. THE FAMILY ALLEGES THE REPLACEMENT PROCEDURE CONTRIBUTED TO THE PATIENTS DEATH.

  Patient problems: Insufficient Information

  MAUDE report 18550478 ↗
• MalfunctionJan 19, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY WHEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 18541635 ↗
• InjuryJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN UNSPECIFIED MALFUNCTION. THE DEVICE 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 18480212 ↗
• MalfunctionDec 15, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT NON-PHYSIOLOGIC NOISE FROM THE DEFIBRILLATION RIGHT VENTRICULAR (RV) LEAD AND PACE/SENSE RV LEAD WAS DETECTED IN THE VENTRICULAR FIBRILLATION (VF)-ZONE RESULTING IN THE PATIENT RECEIVING INAPPROPRIATE THERAPY. REVIEW OF THE DATA INDICATED THAT LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED DURING THE INAPPROPRIATE HIGH VOLTAGE THERAPY. A LEAD INTEGRITY ALERT (LIA) WAS ALSO TRIGGERED THAT DAY DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) WITH NON-PHYSIOLOGIC SENSING, AND AN OBSERVATION FOR HIGH RV THRESHOLDS WAS TRIGGERED A FEW DAYS EARLIER. REVIEW OF THE DATA BY QUALIFIED ENGINEERING PERSONNEL DETERMINED THAT THERE WAS STRONG EVIDENCE OF A LEAD FRACTURE. IT WAS FURTHER REPORTED THAT ADDITIONAL REVIEW OF THE DEVICE DATA INDICATED THAT THE REDUCED-ENERGY SHOCKS MAY HAVE BEEN RELATED TO A COMPROMISED LEAD OR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD AND BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334462 ↗
• InjuryNov 28, 2023Pacing 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 FOR RAPID VENTRICULAR RESPONSE DURING AN ATRIAL ARRHYTHMIA WHEN THE ICD CLASSIFIED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. 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 18221470 ↗
• MalfunctionOct 30, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED THAT BATTER VOLTAGE WAS NOT MEASURED. 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 18029769 ↗
• InjurySep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT ALL THE SHOCKS THE PATIENT RECEIVED WERE APPROPRIATE THERAPY FOR INCESSANT VENTRICULAR TACHYCARDIA (VT). MEDICATION CHANGES WERE MADE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FUNCTIONING NORMALLY.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17699528 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS VEGETATION WITHIN THE PATIENT¿S HEART. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17038959 ↗