Evera MRI™ XT DR SureScan™ DDMB1D1 (UDI 00643169717282)Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 00643169717282), received between Feb 9, 2017 and Sep 30, 2026 — classified as 9 deaths, 168 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (82 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 253 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50951356 ↗
• InjuryJun 15, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A CHRONIC HEMATOMA. A CAPSULECTOMY WAS PERFORMED AT THE SAME TIME AS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). ONE MONTH POST CHANGEOUT, THE PATIENT PRESENTED WITH AN INFECTION AND AN ERODED POCKET. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 25511224 ↗
• MalfunctionMay 19, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND A LOSS OF CAPTURE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENT EXPERIENCED CHEST PAIN. THE RA LEAD AND ICD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25222553 ↗
• MalfunctionMay 4, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INAPPROPRIATELY CLASSIFYING SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES AS MONITORED VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO LOW MATCH SCORES BETWEEN THE PATIENT'S CURRENT QRS COMPLEX AND A STORED TEMPLATE OF THE COMPLEX. 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 25066263 ↗
• MalfunctionMar 17, 2026Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) "FIRED TWENTY-TWO TIMES AND COULD NOT RESTABILIZE" THEIR HEART. THE PATIENT FURTHER STATED THAT "IT KEPT TRYING" BUT THE DEVICE WAS UNABLE TO STABILIZE THEIR ARRHYTHMIA POSSIBLY DUE TO A DEVICE MALFUNCTION. THE PATIENT ALSO NOTED SHORTNESS OF BREATH DURING REHAB. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Shock from Patient Lead(s)

  MAUDE report 24619622 ↗
• MalfunctionFeb 3, 2026Device Sensing Problem

  IT WAS FURTHER REPORTED THAT DURING A DEVICE CHECK THERE WAS NO UNDERSENSING NOTED AND NO INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245697 ↗
• MalfunctionJan 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE RV LEAD DISPLAYED OVERSENSING OF NON-PHYSIOLOGIC INTERVALS. THE RIGHT ATRIAL (RA) LEAD DISPLAYED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA-NON SUSTAINED (VT-NS). IN ADDITION, THE ICD CLASSIFIED AN SVT EPISODE AS MONITORED VT. THE ICD AND LEADS 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 24043839 ↗
• InjuryJan 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR VENTRICULAR TACHYCARDIA (VT)  THAT WAS POSSIBLE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH FAST VENTRICULAR RATES. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. THE ICD AND 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 23989291 ↗
• InjuryJan 6, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE ADVISED THERE WERE THREE MONTHS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY LIFE LEFT BUT IT DEPLETED IN ONE MONTH. THE PATIENT STATED HEARING TONES AND THE PHYSICIAN¿S OFFICE VERIFIED IT WAS FOR LOW BATTERY WITH THREE MONTHS OF BATTERY REMAINING. THE PATIENT STATED THE DEVICE STOPPED TONING A FEW WEEKS LATER AND THEN SHORTLY AFTER, THE PHYSICIAN¿S TEAM ¿COULDN¿T SENSE THE DEVICE.¿ THE ICD 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 23981516 ↗
• InjuryNov 21, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD THERAPY FOR A VENTRICULAR FIBRILLATION (VF) EPISODE DETECTED INITIALLY AS SUPRA VENTRICULAR TACHYCARDIA (SVT) VIA THE SINUS TACHYCARDIA DISCRIMINATOR. VF WAS SUBSEQUENTLY DETECTED AND TREATED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23617597 ↗
• MalfunctionOct 30, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY CLASSIFIED VENTRICULAR TACHYCARDIA (VT) EPISODES AS SUPRA VENTRICULAR TACHYCARDIA (SVT) VIA THE DEVICE FEATURE THAT EVALUATES THE STABILITY OF VENTRICULAR INTERVALS. 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 23429223 ↗
• DeathSep 3, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT WAS DECEASED. IT WAS REPORTED THAT SIX FIRST PHASE SHORT CIRCUIT PROTECTION (SCP) EVENTS WERE TRIGGERED DURING AN EPISODE OF HIGH VOLTAGE THERAPY RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED AND AN ALERT WAS TRIGGERED. THE EPISODE ELECTROGRAMS (EGM) WERE REVIEWED BY QUALIFIED PERSONNEL IN WHICH IT WAS NOTED THAT PRIOR TO THE SCP EVENTS, IT APPEARED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT TRANSITIONED INTO A DUAL TACHYCARDIA IN THE VENTRICULAR FIBRILLATION (VF) ZONE. FOLLOWING A BURST BEFORE CHARGING FOR HIGH VOLTAGE DELIVERY, THE VENTRICULAR ARRHYTHMIA APPEARED TO ACCELERATE AND ALTER IN MORPHOLOGY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM REMAINS IN-SITU.

  Patient problems: Insufficient Information

  MAUDE report 22956904 ↗
• InjuryAug 29, 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 THERAPY FOR AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) WHICH WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) 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 22922923 ↗
• InjuryAug 7, 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 SHOCK FOR DETECTED VENTRICULAR FIBRILLATION (VF) EPISODE THAT WAS POSSIBLE SINUS TACHYCARDIA. 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 22745193 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH SWELLING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22560138 ↗
• InjuryJul 1, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) A HEALTHCARE PROFESSIONAL INDICATED THE PATIENT WAS EXPERIENCING BRADYCARDIA WITH HEART RATE IN THIRTIES AND FORTIES BEATS PER MINUTE (BPM).  THE HEART RATES ARE BELOW THE ICD PROGRAMMED LOWER RATE SETTING.  THE ICD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22379273 ↗
• InjuryJun 30, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)¿S LONGEVITY DROPPED BY TWO MONTHS RECOMMENDED REPLACEMENT TIME (RRT) IN A ¿FAST¿ MANNER. TWO DAYS LATER, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE AND THE ICD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360950 ↗
• InjuryMar 20, 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 INAPPROPRIATE THERAPY FOR DETECTED VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE RHYTHM WAS POSSIBLE 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 21654398 ↗
• InjuryMar 12, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586153 ↗
• InjuryMar 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) PATIENT EXPERIENCED AN INFECTION. THE DEVICE AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21573250 ↗
• MalfunctionJan 29, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE AS FAST VENT RICULAR TACHYCARDIA (FVT). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW R WAVE. 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 21267930 ↗
• InjuryJan 15, 2025Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS SCHEDULED FOR AN ATRIOVENTRICULAR ABLATION AND WAS RESTARTED ON SOME MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 21159556 ↗
• InjuryJan 13, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION, AND HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE ICD 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 21138818 ↗
• InjuryJan 10, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) ARRYTHMIA AND WHILE IN THE HOSPITAL, THE PATIENT'S POTASSIUM WAS NOTED TO BE LOW. MEDICATION WAS ADMINISTERED TO CORRECT IT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21130569 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INFECTIONS AND SEPSIS AND THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 20846265 ↗