Evera MRI™ S DR SureScan® DDMC3D4 (UDI 00643169720527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00643169720527), received between Nov 15, 2018 and Jun 24, 2026 — classified as 2 deaths, 61 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1716-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM) EPISODES RESULTING IN MISCLASSIFICATION OF EPISODES AND RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECT AND TREATED AS FAST VENTRICULAR TACHYCARDIA (FVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED MIS-DETECTION FOR SVT THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE AN LEAD REMAINS 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 25615154 ↗
• MalfunctionApr 3, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY RECENTLY HAD THEIR DEVICE'S LOWER RATE SETTING ADJUSTED AND THEY STARTED GETTING SOME ERRATIC HEART RATE READINGS. THE PATIENT INDICATED THEY HAD HEART RATES IN THE FORTIES, AND AS LOW AS THIRTY-THREE BEATS PER MINUTE. THE PATIENT INQUIRED IF THEIR DEVICE WAS FUNCTIONING CORRECTLY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Irregular Pulse

  MAUDE report 24779562 ↗
• MalfunctionFeb 17, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERING EPISODE M ISCLASSIFICATION. 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 24365362 ↗
• InjuryNov 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 ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE IS STILL IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OCCASIONAL UNDERSENSING DURING AT/AF EPISODES. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23617980 ↗
• InjuryOct 31, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23439358 ↗
• MalfunctionOct 29, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENTS AND APPEARED TO RESULT IN INAPPROPRIATE ATRIAL 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 23417651 ↗
• MalfunctionAug 8, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS NOTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE THAT APPEARED TO BE OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 22755860 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO AN INFECTION. THE SYSTEM W AS REPLACED APPROXIMATELY FOUR WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21376303 ↗
• InjuryDec 12, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN OUT OF RANGE (OOR) HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE WARNING. IN ADDITION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THE RHYTHM WAS POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE RV LEAD AND 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 20920122 ↗
• InjuryOct 3, 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 INFECTION. THE PATIENT EXPERIENCED PURULENT DISCHARGE AND REDNESS AT THE SITE AS A RESULT. THE ICD SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 20358969 ↗
• InjurySep 17, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE. IT WAS NOTED THAT CAUTERY NOISE WAS OBSERVED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF EXTERNAL NOISE. THE ICD WAS EXPLANTED AND REPLACED, THE RA LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241615 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. NO FU RTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19961444 ↗
• InjuryJul 4, 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 A POCKET INFECTION WITH EROSION AND REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Unspecified Infection

  MAUDE report 19675268 ↗
• MalfunctionJun 12, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS EXPERIENCING PREMATURE BATTERY DEPLETION. 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 19520817 ↗
• InjuryApr 2, 2024Premature Discharge of Battery; Failure to Charge; Premature Discharge of Battery; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 130 CONSECUTIVE SHOCKS FOR VENTRICULAR TACHYCARDIA ( VT)/VENTRICULAR FIBRILLATION (VF) EPISODES AND EXHIBITED PREMATURE BATTERY DEPLETION. CLINICAL DATA FROM THE ICD WAS REVIEWED AND IT WAS DETERMINED THAT THE OBSERVED RECOMMENDED REPLACEMENT TIME (RRT) WAS APPROPRIATE BASED ON THE NUMBER OF SHOCKS THE PATIENT RECEIVED. ADDITIONALLY, A CHARGE CIRCUIT TIMEOUT OCCURRED AFTER THE SHOCKS WERE DELIVERED. THE ICD 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 19029428 ↗
• InjuryNov 30, 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) DELIVERED SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF). IT WAS SUSPECTED THAT THE ARRYTHMIA WAS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE.  IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 18238849 ↗
• InjuryNov 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A PRODUCT PERFORMANCE ISSUE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE SYSTEM WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059661 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS. 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 18055639 ↗
• InjuryOct 25, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT FAR FIELD R-WAVE (FFRW) OVERSENSING AND INTERMITTENTLY UNDERSENSING DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AF). THE LEAD REMAINS IN USE.

  Patient problems: Atrial Fibrillation

  MAUDE report 18007299 ↗
• MalfunctionAug 29, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING NOISE ON BOTH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEADS, ELECTROMAGNETIC INTERFERENCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED ELECTROGRAMS (EGM). THE ICD 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 17642889 ↗
• InjuryJun 1, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS REPROGRAMMED AND THE ATRIAL SENSITIVITY WAS ADJUSTED.

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

  MAUDE report 17037258 ↗
• InjuryMay 17, 2023False Positive Result; Defibrillation/Stimulation Problem; Low impedance; False Positive Result; Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT THE DEVICE TRIGGERED SHORT CIRCUIT PROTECTION DURING HIGH VOLTAGE THERAPY RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED. IN ADDITION, A SUBSEQUENT IMPEDANCE DROP BY APPROXIMATELY FIFTY PERCENT ACROSS ALL PACING PATHWAYS WAS OBSERVED WHICH TRIGGERED AN ALERT, ALONG WITH A DECREASE IN THE BATTERY VOLTAGE TRENDS RESULTING IN RECOMMENDED REPLACEMENT TIME (RRT) BEING TRIGGERED. IT WAS NOTED THAT THE LOWER OUTPUT SHOCK WAS ABLE TO CONVERT THE ARRHYTHMIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 16950252 ↗
• MalfunctionJan 30, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT HIGH RATE NON-SUSTAINED EPISODES APPEARED TO BE OVERSENSING NOISE DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE. 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 16264481 ↗
• InjuryJan 10, 2023Premature Discharge of Battery; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Premature Discharge of Battery; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT MODE SWITCHING APPROPRIATELY. REPROGRAMMING WAS DONE. SEVERAL DAYS LATER THE DEVICE DETECTED VENTRICULAR TACHYCARDIA (VT) AND SHOCKED THE PATIENT MULTIPLE TIMES. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL TACHYCARDIA, THEREFORE MAKING THE SHOCK INAPPROPRIATE. THE DAY AFTER THE INAPPROPATE SHOCKS THE DEVICE DETECTED VENTRICULAR TACHYCARDIA (VT) AND SHOCKED THE PATIENT. THIS TIME IT WAS SUSPECTED THAT THE RHYTHM WAS ACTUALLY ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), THEREFORE MAKING THE SHOCKS INAPPROPRIATE. 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 16131637 ↗
• MalfunctionDec 9, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES, HOWEVER IT WAS DETERMINED THAT THE PATIENT WAS NOT IN SVT. 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 15949733 ↗