Evera MRI™ S DR SureScan™ DDMC3D1 (UDI 00763000060015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000060015), received between Mar 3, 2022 and Aug 14, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (6 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-1715-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING NOTED ON A STORED EPISODE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE LEAD AND DEVICE 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 22805824 ↗
• InjuryDec 3, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS NOTED THAT THE DATA SUMMARY REPORT GENERATED BY THE PATIENT MONITORING SYSTEM SHOWED ONE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE HOWEVER EPISODE LIST SHOWED ONGOING AT/AF EPISODE DUE TO A MOBILE PROGRAMMER ERROR. THE MOBILE PROGRAMMER REMAINS IN USE. IT WAS FURTHER REPORTED THAT COMPLICATIONS INCLUDING A PULMONARY EMBOLISM, BILATERAL DEEP VEIN THROMBOSES, A NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND BANDEMIA OCCURRED AS A RESULT OF THIS EVENT. THE PATIENT WAS PRESCRIBED AN ANTIARRHYTHMIC AND AN ANTICOAGULANT MEDICATION FOR TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Myocardial Infarction; Pulmonary Embolism; Shock from Patient Lead(s); Thrombosis/Thrombus

  MAUDE report 20832428 ↗
• InjuryOct 4, 2024Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. APPROXIMATELY ONE WEEK LATER, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. THE RA LEAD 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 20371314 ↗
• InjuryJun 26, 2024Electrical /Electronic Property Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Electrical /Electronic Property Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT EPISODES OF VENTRICULAR FIBRILLATION (VF) AND SUPRA VENTRICULAR TACHYCARDIA (SVT) WERE DETECTED. TWO OF THE EPISODES RESULTED IN THE PATIENT RECEIVING ANTI-TACHYCARDIA PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS UNABLE TO BE DETERMINED IF IT WAS TRULY AN SVT OR A VENTRICULAR ARRHYTHMIA. 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 19618850 ↗
• InjuryJun 13, 2024High impedance; Mechanical Problem; Over-Sensing; Impedance Problem; High impedance; Mechanical Problem; Over-Sensing; Impedance Problem

  IT WAS FURTHER REPORTED THAT THERE WERE SHORT V-V INTERVALS OBSERVED BEFORE AND AFTER THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531467 ↗
• InjuryFeb 29, 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 RECEIVED A SHOCK FOR AN EPISODE DETECTED IN THE FAST VENTRICULAR TACHYCARDIA (FVT) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING. 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: Shock from Patient Lead(s)

  MAUDE report 18812507 ↗
• MalfunctionOct 16, 2023Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATED A GRAY BAR STATUS, INDICATING THAT THE DEVICE BATTERY HAD A PREMATURE DEPLETION AND THE DEVICE WAS NOT SUITABLE FOR IMPLANT. THE DEVICE WAS REMOVED FROM SERVICE. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939232 ↗
• MalfunctionJul 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, DURING A DEVICE CHANGE OUT PROCEDURE, WHEN ATTEMPTING TO RETRACT THE SETSCREW OF THE NEWLY I MPLANTED DEVICE TO INSERT THE SUPERIOR VENA CAVA (SVC) LEAD PIN IN THE SVC PORT, THE RESISTANCE ON THE TORQUE WRENCH DAMAGED/BENT THE TORQUE WRENCH. A SECOND TORQUE WRENCH WAS ATTEMPTED WITH THE SAME RESULTS. THE PHYSICIAN THEN USED A SMALLER WRENCH IN THE WRENCH KIT AND WAS ABLE TO RETRACT THE SETSCREW ENOUGH TO INSERT THE SVC PIN IN THE SVC PORT. 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 17289880 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NINE DAYS POST-IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO AN INFECTION . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16512370 ↗
• MalfunctionMar 3, 2023Failure to Capture; Under-Sensing; Appropriate Device Problem Term/Code Not Available; Failure to Capture; Under-Sensing; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT PROCEDURE, THE NEW ICD WAS ATTEMPTED BUT NOT IMPLANTED DUE TO AN "ISSUE". A DIFFERENT ICD WAS IMPLANTED. ONE DAY AFTER IMPLANT OF THE ICD, THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDEFINED HIGH DEFIBRILLATION IMPEDANCE. THE ICD WAS DETERMINED TO HAVE A SETSCREW ISSUE AND 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 16478211 ↗
• MalfunctionFeb 21, 2023Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE WAS INTERROGATED AND HAD PREMATURE BATTERY DEPLETION WITH A GRAY BAR DISPLAYED. THE DEVICE WAS NOT USED AND IT WAS NOTED THAT A WEEK LATER THE DEVICE WAS INTERROGATED AGAIN AND WAS STILL DISPLAYING A GRAY BAR FOR BATTERY LONGEVITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407516 ↗
• MalfunctionFeb 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONNECTED TO THE LEADS AND TESTED, THE DEVICE LONGEVITY ESTIMATE SHOWED A GRAY BAR. THE ICD WAS NOT USED AND ANOTHER ICD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353720 ↗
• MalfunctionMar 3, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND THE BATTERY LONGEVITY ES TIMATION PRESENTED AS A GRAY BAR INSTEAD OF A NUMERICAL VALUE. THE ICD WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660484 ↗