Evera MRI™ XT DR SureScan® DDMB1D4 (UDI 00643169929203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00643169929203), received between Oct 6, 2017 and Sep 23, 2026 — classified as 3 deaths, 185 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (90 reports).

1 FDA recall record name this device's identifier.

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. 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 260 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50871078 ↗
• MalfunctionSep 23, 2026Pacing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited atrial events falling in blanking period resulting in the device classified termination of AT/AF detected events with some unnecessary atrial pacing. 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 50870245 ↗
• MalfunctionJun 16, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS BEEPING EVERYDAY AT 7:30AM, AND HAD THE DEVICE FOR NINE YEARS AND IT'S NEVER DONE THIS. IT STARTED WHEN THE PATIENT WAS IN THE HOSPITAL THREE WEEKS AGO. I'M ASSUMING THERE IS A PROBLEM WITH THE DEVICE. WHY WOULD NOT THE DOCTOR TELL US ABOUT THIS BEEPING SOUND?" THE PATIENT WAS EDUCATED ON PATIENT ALERT TONES AND REFERRED TO THE HEART CLINIC. 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 25522672 ↗
• InjuryJun 12, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLAINT OF CHEST PAIN AFTER RECEIVING A POSSIBLE INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE AND DETECTED AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Shock from Patient Lead(s)

  MAUDE report 25484937 ↗
• MalfunctionMay 22, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL DUE TO  ELECTROMAGNETIC INTERFERENCE DURING STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. IT WAS NOTED THAT THIS WAS OBSERVED DURING A POST OPERATIVE CHECK. 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 25260529 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 24782480 ↗
• MalfunctionApr 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH PACING IMPEDANCE AND FLUCTUATING, HIGH, AND A SPIKE IN DEFIBRILLATION IMPEDANCE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS SUSPECTING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN UNKNOWN MALFUNCTION. THE LEAD REMAINS IN USE. 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 24767790 ↗
• InjuryFeb 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS 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 24446032 ↗
• InjuryJan 14, 2026Failure to Charge; Battery Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072241 ↗
• InjuryDec 9, 2025Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS FURTHER REPORTED THAT THE PATIENT WENT INTO TORSADES AND RECEIVED FORTY SHOCKS. THE PHYSICIAN BELIEVED THAT THE TORSADES WAS DUE TO R-ON-T.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757392 ↗
• InjuryNov 14, 2025Failure to Charge; False Positive Result; Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Failure to Charge; False Positive Result; Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  IT WAS REPORTED THAT LONG CHARGE TIME AND CHARGE CIRCUIT TIMEOUT OCCURRED FOR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH HAD REACHED END OF SERVICE (EOS). IT WAS NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP). IT WAS ALSO NOTED THAT ONE OF THE HIGH VOLTAGE THERAPIES DELIVERED MORE THAN THE PROGRAMMED HIGH VOLTAGE ENERGY. THE 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 23560291 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS AND BACTEREMIA. THE SOURCE OF THE INFECTION WAS UNKNOWN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND THEN REPLACED TWELVE DAYS LATER WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Endocarditis

  MAUDE report 23555785 ↗
• InjuryNov 11, 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 AN INFECTION. NO FURTHER PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23524794 ↗
• InjuryNov 10, 2025Pacing 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 ANTI-TACHYCARDIA PACING AND SHOCKS FOR AN EPISODE DETECTED AS VENTRICULAR TACHYCARDIA (VT), HOWEVER, THE RHYTHM WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN MISCLASSIFICATION OF EPISODES AND TERMINATION OF ATRIAL TACHYCARDIA (AT) / ATRIAL FIBRILLATION (AF) DETECTED EVENTS IN PROGRESS. CHEST PAIN WAS NOTED. THE ICD AND THE RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Shock from Patient Lead(s)

  MAUDE report 23513421 ↗
• InjuryNov 6, 2025Pacing 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) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE ICD DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). 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 23486613 ↗
• InjuryNov 4, 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 POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS VENTRICULAR TACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL UNDER SENSING RESULTING IN MISCALCULATION OF ARRHYTHMIA EPISODE TYPE. 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 23468416 ↗
• InjuryNov 3, 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 POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUPRA VE NTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. 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 23447375 ↗
• MalfunctionSep 19, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR THAT IS USED TO DISTINGUISH BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS INAPPROPRIATELY LABELLED VENTRICULAR TACHYCARDIA (VT) AS 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 23095174 ↗
• MalfunctionAug 20, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE 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 22855028 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION POST BYPASS PROCEDURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22676976 ↗
• InjuryJul 9, 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 SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE 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 22457451 ↗
• InjuryJul 1, 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 ANTIARRHYTHMIC PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE AN ATRIAL ARRYTHMIA 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 22373229 ↗
• InjuryMay 1, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AND REPRODUCIBLE NOISE AND A RANGE OF MOTION WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 21944658 ↗
• InjuryApr 25, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED AS VENTRICULAR TACHYCARDIA (VT) WHICH WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT) AND THEN THE RHYTHM ACCELERATED TO TRUE VT REQUIRING A SHOCK. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO TRIGGERING NORMAL RECOMMENDED REPLACEMENT TIME (RRT). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21913861 ↗
• InjuryMar 27, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A STERNUM LEAD REMOVAL PROCEDURE, THE DEVICE APPEARED TO BE OVERSENSING POSSIBLE NOISE ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WHICH LED TO INAPPROPRIATE SHOCKS. ADDITIONALLY, A RV LEAD INTEGRITY ALERT (LIA) ALSO OCCURRED DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC), WHICH ALSO OCCURRED DURING THE TIME OF THE PROCEDURE. 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 21709607 ↗