Evera MRI™ S DR SureScan® DDMC3D4 (UDI 00643169314139)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00643169314139), received between Oct 6, 2016 and Jun 15, 2026 — classified as 3 deaths, 47 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 3, 2021Class IOpen, 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 · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0585-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODES THAT WERE SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS NOTED THAT THE DEVICE DISCRIMINATOR INITIALLY WITHHELD THERAPY BUT THE TEMPLATE WAS OLDAND THE MATCH SCORES WERE LOW. 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 25507287 ↗
• MalfunctionMay 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH THE PATIENT¿S HEART RATE (HR) DIPPING IN THE FORTIES ON TELEMETRY. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON ELECTROGRAMS DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND ALSO LEADING TO UNNECESSARY ATRIAL PACING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25154580 ↗
• InjuryJan 29, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT OVER A PERIOD OF THREE DAYS, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED A FASTER THAN EXPECTED BATTERY VOLTAGE DROP. THE UNEXPLAINED LONGEVITY DIP TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT). 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 21265162 ↗
• MalfunctionNov 4, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED, THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED). FOR SHORTNESS OF BREATH. AND REPORTED, HEART RATE IN THE 40 BEATS PER MINUTE (BPM) RANGE. FOUR DAYS LATER, THE PATIENT HAD CHEST PAIN AND HEART RATE OF 35 BPM AT TIMES. THE PATIENT REPORTED, THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT FUNCTIONING, WHEN THEY HAD PREMATURE VENTRICULAR CONTRACTIONS (PVC). REVIEW OF THE REMOTE MONITORING TRANSMISSION SHOWED, THAT THE ICD PROGRAMMED LOWER RATE WAS 40 BPM. AND THE PVC/ECTOPIC BEATS APPEARED TO RESET THE TIMING MECHANISM OF THE ICD. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain; Dyspnea

  MAUDE report 20604561 ↗
• MalfunctionOct 17, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED RAPID BATTERY DEPLETION WITH LARGE UNEXPLAINED DROPS IN BATTERY VOLTAGE OVER THE PAST FEW MONTHS, LEADING TO RECOMMENDED REPLACEMENT TIME (RRT). 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 20476957 ↗
• MalfunctionOct 2, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE FUNCTION WAS NOT AFFECTED BY THE RIGHT ATRIAL (RA) LEAD UNDERSENSING.

  Patient problems: Bradycardia

  MAUDE report 20351531 ↗
• InjurySep 27, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THERE WAS UNDERSENSING OBSERVED ON THE ATRIAL AND VENTRICULAR LEADS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (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 20325034 ↗
• InjurySep 10, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20180707 ↗
• InjuryAug 9, 2024Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT STORED ELECTROGRAMS (EGM) SHOWED NOISE AND OCCASIONAL OVERSENSING CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WENT SWIMMING AT A HOTEL AT THE TIME OF THE EVENT AND IT WAS SUSPECTED THAT THE EMI WAS DUE TO THE SWIMMING POOL. 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 19955900 ↗
• InjuryJul 23, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808954 ↗
• InjuryJun 5, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING A SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT HAD BEEN TREATED FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (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 19470562 ↗
• InjuryMay 17, 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 MULTIPLE SHOCKS. AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATION SHOWED ANTI-TACHYCARDIA PACING AND SHOCKS WERE DELIVERED FOR EPISODES DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) ZONES, AS WELL AS FOR DETECTED FAST VT (FVT). IT WAS SUSPECTED THAT THERAPIES WERE INAPPROPRIATELY DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) OR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD WAS LATER EXPLANTED AND REPLACED FOR A ROUTINE GENERATOR CHANGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19342386 ↗
• MalfunctionMar 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS "DISPLACED" AND "IS POPPING OUT". IT WAS ALSO NOTED 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 18818620 ↗
• InjuryDec 11, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED FEELING LIGHTHEADED. A REVIEW OF THE DEVICE DATA REVEALED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR) 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: Dizziness; Shock from Patient Lead(s)

  MAUDE report 18302786 ↗
• InjuryOct 26, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012625 ↗
• InjuryOct 10, 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) SYSTEM WAS EXPLANTED DUE TO A METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS INFECTION. IT WAS NOTED THAT THE SOURCE WAS POSSIBLY A FOOT INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 17908649 ↗
• MalfunctionSep 22, 2023Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS OBSERVED. IN ADDITION, THERE WAS ATRIAL OVERSENSING NOTED ON ONE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RECORDED EPISODE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (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 17798688 ↗
• InjurySep 8, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714668 ↗
• InjuryApr 12, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) WHICH WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 16724874 ↗
• MalfunctionDec 7, 2022Electromagnetic Interference; Over-Sensing; Pacing Problem; Electromagnetic Interference; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, OVERSENSING ON THE RIGHT ATRIAL (RA) AND THE RV LEAD WAS NOTED ON STORED ELECTROGRAMS (EGM) THAT APPEAR TO BE ELECTROMAGNETIC INTERFERENCE AND AT TIMES INHIBITED PACING. 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 15932559 ↗
• InjuryJun 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED SUDDEN DROP IN BATTERY VOLTAGE AND LONGEVITY. 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 14854195 ↗
• InjuryJan 24, 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 A POCKET INFECTION.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13334167 ↗
• InjuryJan 18, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13284926 ↗
• InjuryNov 30, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE FIRST SHOCK FOR SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WAS APPROXIMATELY 10 MONTHS BEFORE THE SECOND SHOCK.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12902203 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A VALVULAR INFECTION AND 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 12771435 ↗