Evera MRI™ XT DR SureScan® DDMB1D4 (UDI 00643169314092)Recalls & reported problems

Summary

The FDA's MAUDE database contains 945 adverse event reports that list this exact device (DI 00643169314092), received between Dec 9, 2016 and Sep 29, 2026 — classified as 24 deaths, 640 injuries, 281 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (284 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 945 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and shocks for Supra Ventricular Tach ycardia (SVT) detected as Ventricular Fibrillation (VF). Additionally, the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events. 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 50938082 ↗
• InjurySep 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763404 ↗
• MalfunctionSep 10, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722933 ↗
• InjurySep 9, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that  the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate Anti-Tachycardia Pacing (ATP) and shocked for Supra Ventricular Tachycardia (SVT)  which the device detected and treated as Ventricular Tachycardia (VT). 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 50689736 ↗
• MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543348 ↗
• InjuryAug 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that there was undersensing on the Right Ventricular (RV) lead and Far Field R-Wave (FFRW) oversensing on the Right Atrial (RA) lead. It was also noted the Implantable Cardioverter Defibrillator (ICD) possibly detected Supra Ventricular Tachycardia (SVT) as Ventricular Fibrillation (VF) and monitored Ventricular Tachycardia (VT). The VF detection resulted in Anti-Tachycardia Pacing (ATP) and high voltage therapy. The leads 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 50431593 ↗
• MalfunctionAug 20, 2026Battery Problem

  Patient problems: Confusion/ Disorientation

  MAUDE report 50357329 ↗
• InjuryAug 4, 2026Failure to Deliver Shock/Stimulation

  It was reported by a nurse that the Implantable Cardioverter Defibrillator (ICD) failed to treat an episode of Ventricular Tachycard ia (VT). It was noted the patient was unresponsive during the episode and required external defibrillation. Upon technical review, it was noted that the ventricular rate during the episode fell into the monitor only zone, so it did not meeting rate zone criteria for therapy. The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50132247 ↗
• MalfunctionJul 27, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045509 ↗
• InjuryJul 13, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD FAINTED AND REPORTED AND WERE ADMITTED TO THE HOSPITAL THAT HAD IMPLANTED THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25798412 ↗
• InjuryJul 8, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT THAT THEY HAD INSTANCES OF BLACKING OUT AND CHEST PAINS. THE PATIENT REPORTED BEING INFORMED BY THEIR DOCTOR THAT THE ICD SHOULD HAVE SHOCKED THEM. THE PATIENT WAS REPORTEDLY PRESCRIBED A HEART MONITOR WHERE "SKIPPING" WAS OBSERVED THREE TIMES. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Syncope/Fainting

  MAUDE report 25749389 ↗
• InjuryJul 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF). FOLLOWING THE ATP DELIVERY THE RATES WERE NOTED TO HAVE INCREASED IN ADDITION TO A MORPHOLOGY CHANGE, AND HIGH VOLTAGE THERAPY WAS APPROPRIATELY DELIVERED.  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 25725233 ↗
• InjuryJun 26, 2026Misconnection

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE, UNDEFINED PACING IMPEDANCE AND A LARGE NUMBER OF SHORT V-V INTERVALS. DURING THE REPLACEMENT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE, THE PHYSICIAN OBSERVED TISSUE/DEBRIS WITHIN THE CONNECTOR PORT/HEADER AREA. AFTER CONNECTING THE RV LEAD TO A NEW ICD, IMPEDANCE, SENSING, AND PACING MEASUREMENTS NORMALIZED. THE RV 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 25637967 ↗
• MalfunctionJun 18, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND SHORTNESS OF BREATH AND THE NURSE MENTIONED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STARTED PACING THE PATIENT AFTER THE EMERGENCY MEDICAL SERVICES (EMS) TEAM WENT OVER A ROCK. ADDITIONALLY, RIGHT ATRIAL (RA) LEAD UNDERSENSING WAS OBSERVED RESULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES IN PROGRESS AND UNNECESSARY ATRIAL PACING AT TIMES. A FAILED ATRIAL LEAD POSITION CHECK WAS OBSERVED AND IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE INAPPROPRIATELY CLASSIFIED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WITH FAST VENTRICULAR RESPONSE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 25552590 ↗
• InjuryJun 12, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THERE WERE ISSUES WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT REPORTEDLY KEPT RECEIVING SHOCKS WHILE SLEEPING DURING THE NIGHT BUT THE SHOCKS WERE NOT SHOWING UP ON THE PATIENT'S REPORTS. THE PATIENT WENT IN TO THEIR CLINIC AND ADJUSTMENTS WERE MADE, MORE SPECIFICALLY THEY HAD SOMETHING TURNED DOWN; HOWEVER, THE SHOCKS CONTINUED. THE PATIENT BELIEVED SOMETHING WAS WRONG WITH THE DEVICE. 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 25483616 ↗
• MalfunctionJun 3, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED DETECTION ISSUE AS THE DEVICE DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT). 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 25382610 ↗
• InjuryMay 12, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATOR COIL IMPEDANCE. THE RV LEAD REMAINS IN USE. IT WAS ALSO 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 25150265 ↗
• MalfunctionApr 21, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED FAST ATRIAL AND VENTRICULAR ARRHYTHMIA AS NO N-SUSTAINED VENTRICULAR TACHYCARDIA. 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 24947968 ↗
• InjuryApr 20, 2026Appropriate Device Problem Term/Code Not Available

  FOLLOW UP WITH THE CLINIC FOUND THAT THE PATIENT HAS NOT BEEN SEEN IN CLINIC FOR SEVERAL YEARS AND IS NOT SET UP WITH REMOTE MONITORING. THE CLINIC HAD NO FURTHER INFORMATION.

  Patient problems: Cardiac Arrest

  MAUDE report 24930745 ↗
• MalfunctionApr 20, 2026Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ELECTRICAL NOISE WAS NOTED, LIKELY FROM CONTACTING SOMETHING POORLY GROUNDED. 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 24928120 ↗
• InjuryMar 19, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POSSIBLY EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AS THE DEVICE DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) INSTEAD. THE DEVICE WITHHELD THERAPY INAPPROPRIATELY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24641828 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT THAT THEIR HEART RATE HAD BEEN RACING AND THEN SLOWING DOWN AND THEY HAD BAD ATRIAL FIBRILLATION (AF). THE PATIENT REPORTED BEING HOSPITALIZED ON AND OFF FOR THE LAST THREE MONTHS. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 24455359 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT THAT THE EXPERIENCED AN ENDOCARDITIS INFECTION. THE PATIENT WAS HOSPITALIZED AND THE DEVICE SYSTEM WAS EXPLANTED AND THE PATIENT WAS GIVEN AN EXTERNAL DEFIBRILLATOR VEST. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 24432795 ↗
• InjuryFeb 24, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AND WAS "NOT DOING WELL". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 24429688 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24365850 ↗