Evera MRI™ XT DR SureScan® DDMB1D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 00763000059521), received between Feb 8, 2018 and Aug 20, 2026 — classified as 6 deaths, 160 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (78 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 16, 2026.

Recalls naming this device

1. May 10, 2023Open, 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-1711-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Device Sensing Problem

  It was reported that during use the Implantable Cardioverter Defibrillator (ICD) exhibited abnormal sensing.  The ICD remains in use .  No patient complications have been reported as a result of this event.  The patient is a participant in a clinical study.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348153 ↗
• MalfunctionMay 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HAVE BEEN HAVING PROBLEMS WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT NOTED THAT THEY HAVE ¿LANDED IN THE HOSPITAL THREE TIMES SHOWING AN ARRHYTHMIA¿ AND THE ICD ¿SHOWS BIG PEAKS AND THEN IT SHUTS OFF BY ITSELF.¿ THE PATIENT ALSO NOTED THAT THEY DO NOT FEEL GOOD A LOT OF TIMES AND THEIR ¿BLOOD PRESSURE GOES UP AND STOPS BY ITSELF.¿ THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25302800 ↗
• MalfunctionMay 20, 2026Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS NO TELEMETRY WITH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25232916 ↗
• MalfunctionMay 4, 2026Electromagnetic Interference; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI). THE ICD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE RA 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 25069635 ↗
• MalfunctionMar 13, 2026Battery Problem

  AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING THE RECOMMENDED REPLACEMENT TIME (RRT) WITH NO COMPLAINT INFORMATION. DURING THE MANUFACTURER¿S PRELIMINARY ANALYSIS, THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589999 ↗
• MalfunctionMar 11, 2026Electromagnetic Interference; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED ELECTROMAGNETIC INTERFERENCE (EMI)/NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL RESULTING IN MISCLASSIFICATION OF EPISODE TYPE AND INAPPROPRIATE THERAPY. THERE WAS OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL RESULTING IN INHIBITION OF PACING. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EVENTS AND INCREASED SENSING INTEGRITY COUNTER (SIC). 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 24569613 ↗
• MalfunctionFeb 27, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING FALSE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) DETECTIONS. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) IN THE MONITOR ZONE THAT MAY HAVE BEEN SUPRA VENTRICULAR TACHYCARDIA (SVT), NO THERAPY WAS DELIVERED. 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 24471499 ↗
• InjuryFeb 19, 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 ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE 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 24389519 ↗
• MalfunctionFeb 16, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. THE ICD AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349724 ↗
• InjuryDec 19, 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 (ATP) AND A SHOCK FOR A DETECTED VENTRICULAR FIBRILLATION (VF) EPISODE THAT WAS SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. 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 23850659 ↗
• InjuryDec 16, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED 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 23816817 ↗
• InjuryDec 2, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER RECEIVING MULTIPLE THERAPIES FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODES. THERE WAS A DISCUSSION TO DETERMINE IF THE EPISODES LOOKED APPROPRIATE WITH MULTIPLE PHYSICIANS AND PERSONNEL WHICH CAME TO VARIOUS CONCLUSIONS. REVIEW OF THE INTERROGATION REPORT SHOWED THAT THE TREATED VT EPISODES APPEARED TO BE DUAL TACHYCARDIA, AND THE PATIENT HAD A DUAL TACHYCARDIA STORM. THE MANAGING ELECTROPHYSIOLOGIST (EP) REQUESTED TO TURN OFF DEVICE THERAPIES FOR THE VT ZONE. THE DEVICE 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 23697493 ↗
• InjuryNov 17, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE DELIVERED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE 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: Shock from Patient Lead(s)

  MAUDE report 23573255 ↗
• MalfunctionNov 12, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPROGRAMMED TO REDUCE AF CURRENT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532803 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH EROSION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 23490260 ↗
• InjuryNov 5, 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 REMOVED DUE TO POCKET EROSION AND POSSIBLE INFECTION. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23477387 ↗
• InjuryOct 24, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED IT AS A DOUBLE TACHYCARDIA. 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 23382016 ↗
• InjurySep 4, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THE PATIENT WAS SEEN IN CLINIC AND IT WAS NOTED THE PATIENT WAS NON-COMPLIANT WITH THEIR MEDICATIONS AT THE TIME OF THE EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22963606 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22862517 ↗
• InjuryAug 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 AND REPLACED TWO WEEKS LATER DUE TO A POCKET INFECTION INVOLVING REDNESS AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 22779129 ↗
• InjuryAug 7, 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 INFECTION. THE PATIENT EXPERIENCED BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 22738118 ↗
• InjuryAug 4, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED VIA FOLLOW UP WITH THE PATIENT'S FOLLOWING PHYSICIAN THAT THE THERAPIES WERE APPROPRIATE

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22702944 ↗
• InjuryAug 1, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF).  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 22691361 ↗
• InjuryJul 29, 2025Signal Artifact/Noise; Failure to Deliver Shock/Stimulation; Over-Sensing; Device Sensing Problem; Signal Artifact/Noise; Failure to Deliver Shock/Stimulation; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITHHELD INAPPROPRIATELY FOR EPISODES OF VENTRICULAR TACHYCARDIA (VT) WHICH WERE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. IT WAS FURTHER REPORTED THAT OVERSENSING NOISE WAS OBSERVED DURING IMPEDANCE TESTING. REPROGRAMMING WAS PERFORMED AND THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Tachycardia

  MAUDE report 22645464 ↗
• InjuryJul 17, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE.

  Patient problems: Syncope/Fainting

  MAUDE report 22530543 ↗