Evera MRI™ S DR SureScan™ DDMC3D1 (UDI 00643169717244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169717244), received between Feb 9, 2017 and May 20, 2025 — classified as 2 deaths, 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• DeathMay 20, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT¿S SPOUSE INDICATED THEY WERE TOLD THAT IF THE HEART WAS ABOUT THE HAVE A FAILURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WOULD ACT AND AVOID FOR THAT TO HAPPEN. ADDITIONALLY, THE PATIENT¿S SPOUSE INDICATED THE PATIENT MAY ALSO SHOW A PHYSICAL REACTION DUE TO A SHOCK IN SUCH A SCENARIO. THE CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. ADDITIONALLY, IT WAS REPORTED THAT THE REMOTE MONITOR MISSED LAST SCHEDULED TRANSMISSION. NO TROUBLESHOOTING TAKEN. SCHEDULED TRANSMISSION DID NOT TAKE PLACE AS NEW REMOTE MONITOR WAS NOT SETUP. THE MONITOR IS EXPECTED TO BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 22051444 ↗
• MalfunctionDec 6, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 20871225 ↗
• InjuryOct 28, 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) WAS EXPLANTED DUE TO INFECTION. THE ORGANISM OF THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection

  MAUDE report 20552316 ↗
• InjuryAug 15, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING AND EXTERNAL NOISE, WHILE IN A SURGICAL PROCEDURE. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE LEAD TRENDS WERE LATER NOTED TO BE WITHIN EXPECTED RANGE. 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 19990624 ↗
• InjuryJan 22, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 18551910 ↗
• InjuryNov 2, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) APPROPRIATELY DETECTED VENTRICULAR FIBRILLATION (VF) AND PROVIDED APPROPRIATE ANTI-TACHYCARDIA PACING AND ONE APPROPRIATE SHOCK, THE RHYTHM CHANGED TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, BUT THE ICD SHOCKED TWO MORE TIMES FOR VF. ADDITIONALLY, IT WAS NOTED THAT THERE WAS RIGHT VENTRICULAR (RV) LEAD UNDERSENSING DURING VENTRICULAR FIBRILLATION (VF) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES, AND INTERMITTENT RIGHT ATRIAL (RA) LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES, THE RA UNDERSENSING DID NOT APPEAR TO ALTER DEVICE DETECTION OR TERMINATION OF EVENTS. THE ICD AND LEADS 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 18055664 ↗
• InjuryAug 10, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

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

  Patient problems: Ventricular Fibrillation

  MAUDE report 17499845 ↗
• InjuryApr 6, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD DETECTION DURING THE PATIENT'S VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 16690396 ↗
• MalfunctionDec 6, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED VIA THE REMOTE MONITORING SYSTEM. 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 15927484 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE CUT, CAPPED, AND PARTIALLY REMOVED WITH THE REMAINING PORTION OF THE LEADS LEFT IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15761098 ↗
• InjuryNov 9, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR VENTRICULAR FIBRILLATION (VF) THAT WAS POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). 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 15759419 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FROM A LEAD EXPOSED THROUGH THE SKIN AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE ICD SYSTEM WAS EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 15420981 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11423564 ↗
• InjuryJan 21, 2021Adverse 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. A NEW SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11207354 ↗
• InjuryDec 2, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS PREMATURELY. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936123 ↗
• MalfunctionMay 8, 2018Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) APPEARS TO BE UNDERSENSING THE ATRIAL ARRHYTHMIAS WITH THE RIGHT ATRIAL (RA) LEAD¿S SENSITIVITY PROGRAMMED AT 0.45MV (MILLIVOLTS), AND THEREFORE IS ATRIAL PACING INAPPROPRIATELY AND AT/AF (ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION) BURDEN MAY NOT BE ACCURATE. THE ICD AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7495369 ↗
• InjuryApr 30, 2018Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT HAD AN ELEVATED HEART RATE LEADING TO T-WAVE OVERSENSING (TWOS) AND WAS SHOCKED TWICE AS A RESULT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2018: IT WAS FURTHER REPORTED THAT ABOUT THREE MONTHS POST IMPLANT OF THE PATIENT¿S NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DURING AN EXERCISE PERIOD WHEN HR (HEART RATE) WAS ELEVATED AND T-WAVE OVERSENSING OCCURRED. THE ICD DID NOT WITHHOLD DELIVERING SHOCK THERAPY FOR THE T-WAVE OVERSENSING AS THE ICD HAD DETERMINED IT AS A VENTRICULAR FIBRILLATION (VF) EPISODE. IT WAS NOTED THAT ALL SHOCK DISCRIMINATORS WERE ON. THE ICD WAS REPROGRAMMED AND 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 7473817 ↗
• MalfunctionApr 24, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT A REVIEW OF STORED EGMS (ELECTROGRAMS) INDICTED THAT THERE WAS OCCASIONAL P-WAVE UNDERSENSING OF THE RIGHT ATRIAL (RA) LEAD DURING ARRHYTHMIA. THE RA LEAD REMAINS IN USE. ADDITIONALLY, IT WAS REPORTED THREE DAYS LATER THAT THERE WAS POSSIBLE INITIATION OF VENTRICULAR ARRHYTHMIA RELATED TO ATRIAL ANTI-TACHYCARDIA PACING FOR ATRIAL ARRHYTHMIA FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454924 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN RESPONSE TO THE ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROPHYLACTICALLY REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY, THE ICD WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7417987 ↗
• DeathApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE PATIENT IS DECEASED. IT WAS ALSO REPORTED THE DEFIBRILLATOR "DID NOT WORK, AND DID NOT SLOW DOWN THE HEART RATE FIVE DAYS BEFORE DEATH." A REQUEST FOR THE CAUSE OF DEATH WAS MADE AND IT WAS LISTED AS PNEUMONIA.

  Patient problems: Death

  MAUDE report 7404492 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOURTEEN DAYS POST IMPLANT A POCKET EVACUATION WAS PERFORMED. THE ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) POCKET WAS OPENED, THE POCKET WAS CLEANED UP, AND THEN THE POCKET WAS SUTURED CLOSED AGAIN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 6920725 ↗
• MalfunctionAug 17, 2017Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD READING AND T-WAVE OVERSENSING (TWOS) WHICH WAS NOT WITHHELD BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) T-WAVE OVERSENSING (TWOS) DISCRIMINATOR. IT WAS NOTED THE CURRENT EKG SHOWED THE T-WAVES WERE LARGER THAN THE R-WAVES. FOLLOW-UP WAS COMPLETED WITH THE CLINIC AND THE HEALTHCARE PROFESSIONAL (HCP) VERIFIED THAT REPROGRAMMING HAD BEEN COMPLETED. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802235 ↗
• InjuryAug 9, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SHORTLY AFTER A DEVICE CHANGEOUT PROCEDURE, THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED ALERTS FOR ELEVATED/HIGH IMPEDANCE AND IMPEDANCE SPIKES. AN INCREASE IN SENSING INTEGRITY COUNTER (SIC) WAS ALSO NOTED. IT WAS THOUGHT A CONNECTION ISSUE BETWEEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD COULD BE THE ISSUE. AN X-RAY WAS TAKEN AND IT LOOKED LIKE THE LEAD PIN WAS NOT FULLY INSERTED INTO THE ICD HEADER. DURING THE REVISION PROCEDURE THE PHYSICIAN COULD NOT VISUALIZE THE LEAD PIN PAST THE GROMMET. A WRENCH WAS USED TO UNSCREW THE LEAD PIN SETSCREW AND THEN THE PHYSICIAN PUSHED ON THE LEAD AND IT ADVANCED ABOUT 1.5MM. THE PHYSICIAN THEN TIGHTENED THE SETSCREW AND EVERYTHING TESTED NORMAL. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781851 ↗
• InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVE OF A DEVICE CHANGEOUT, THE PATIENT DEVELOPED A TIA (TRANSIENT ISCHEMIC ATTACK) AND WAS GIVEN ANTICOAGULATION MEDICATION (ELIQUIS). SUBSEQUENTLY, THE PATIENT DEVELOPED A POCKET HEMATOMA. THE PATIENT ULTIMATELY RECOVERED AND WAS DISCHARGED HOME WITH A SMALL POCKET HEMATOMA. HOWEVER, THIS PROGRESSED WITH THE PATIENT NOTED TO HAVE BLOODY DISCHARGE DRAINING FROM THE POCKET INCISION SITE. THE PATIENT WAS GIVEN ANTIBIOTICS EMPIRICALLY (BACTROBAN AND CLINDAMYCIN). THREE DAYS LATER THE PATIENT WAS ADMITTED AND STARTED ON IV (INTRAVENOUS) ANTIBIOTICS. THE POCKET WAS REVISED WITH WASHOUT AND HEMATOMA EVACUATION. THE EVENT WAS CONSIDERED RESOLVED AND THE DEVICE REMAINS IN USE. THE EVENT WAS NOTED TO BE RELATED TO THE PROCEDURE. THE PATIENT WAS NOTED TO BE ENROLLED IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL (WRAP-IT) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discharge; Headache; Hematoma; Transient Ischemic Attack; Visual Impairment; Weakness

  MAUDE report 6321015 ↗