Amplia MRI™ CRT-D SureScan™ DTMB1D4 (UDI 00643169720718)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169720718), received between Mar 11, 2019 and Jan 8, 2026 — classified as 1 death, 43 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (21 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 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, 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-1762-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED PREMATURE BATTERY DEPLETION. THE DEVICE 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 24004100 ↗
• InjuryDec 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED PREMATURE BATTERY DEPLETION. THE CRTD 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 23717091 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO ENTEROCOCCUS BACTERIA INFECTION WITH BACTEREMIA AND VEGETATION NOTED AROUND THE TRICUSPID VALVE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Medical device site infection; Muscle Weakness/Atrophy

  MAUDE report 22635816 ↗
• InjuryJun 25, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. UPON INTERROGATION PRE-GENERATOR CHANGE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. CHRONIC LOW IMPEDANCES AND AN ELEVATED RV THRESHOLD WERE ALSO NOTED. THE RV LEAD WAS REPROGRAMMED AND THE CRT-D 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 22331822 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21863857 ↗
• InjuryJan 9, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114495 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD BECOME INFECTED AND THE PATIENT HAD BEEN HOSPITALIZED FOR THE PAST THREE WEEKS. THE DEVICE WAS SUPPOSED TO BE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21053611 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO SEPSIS INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS SUBSEQUENTLY PLACED TEN DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 20334838 ↗
• InjurySep 27, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS WAS POSSIBLY TRIGGERING ONSET OF SEVERAL VENTRICULAR FIBRILLATION (VF) AND NON SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. THE CRT-D REMAINS IN USE NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 20327130 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE CRTD SYSTEM WAS REPLACED. STAPHYLOCOCCUS EPIDERMIS WAS ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 18861775 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM INFECTION OCCURRED.  ADDITIONALLY, RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD APPEARED TO HAVE VEGETATION.   THE CRT-D SYSTEM WAS EXPLANTED.  A EPICARDIAL LEFT VENTRICULAR (LV) LEAD WAS PLACED FOR FUTURE USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18223163 ↗
• InjuryAug 16, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING WHEN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POTENTIALLY INAPPROPRIATELY CLASSIFIED THE PATIENT'S ARRHYTHMIAS AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558808 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION. IT WAS NOTED THE INFECTION WAS NOT IMPLANT RELATED, HOWEVER, NO SOURCE WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17503817 ↗
• MalfunctionMay 22, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD BIPOLAR AND TIP TO CAN THRESHOLD VALUES HAD INCREASED, ALONG WITH A SLIGHT INCREASE IN IMPEDANCE VALUES. IT WAS NOTED THAT THE CLINICIAN OBSERVED A SIGNIFICANT DECLINE IN BATTERY LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D 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 16974029 ↗
• DeathMay 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT, WHO WAS IN HOSPICE DUE TO CHRONIC SYSTOLIC HEART FAILURE, EXPIRED. THE PATIENT'S SPOUSE BELIEVED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS STILL ON AT THE TIME OF THE PATIENT'S PASSING AND QUESTIONED WHY THE DEVICE DID NOT SAVE THE PATIENT. THE PATIENT'S SPOUSE ALLEGED THAT THE DEVICE WAS RELATED TO THE PATIENT'S DEATH. THE PATIENT LAST SENT A REMOTE DEVICE INTERROGATION TO THEIR FOLLOWING PHYSICIAN TEN DAYS PRIOR TO THEIR PASSING AT WHICH TIME NO PRODUCT PERFORMANCE ISSUES WERE NOTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 16849190 ↗
• InjuryMar 9, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D 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 16513663 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ECHOCARDIOGRAM SHOWED A THROMBUS/VEGETATION ON THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN DECIDED TO DO AN ANGIO VAC AND REMOVE AS MUCH OF THE SYSTEM AS POSSIBLE. ALL LEADS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 16422957 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO LEAD EROSION RESULTING FROM A SUSPECTED INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED AS A BRIDGE AND THE CRT-D SYSTEM SUBSEQUENTLY EXPLANTED ONE DAY LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 16243856 ↗
• InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT VENTRICULAR (LV) LEAD EXHIBITED A MALFUNCTION. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED APPROXIMATELY SIX WEEKS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041455 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14734982 ↗
• MalfunctionJun 8, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Protective Measures Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Protective Measures Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED ELECTROMAGNETIC INTERFERENCE THAT PRESENTED AS OVERSENSING AND NOISE THAT TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE-NON SUSTAINED EPISODES, SENSING INTEGRITY COUNTER (SHORT V-V INTERVALS) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. IT WAS NOTED THAT THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE AT THE TIME OF THE EPISODES AND THE ELECTROMAGNETIC INTERFERENCE WAS LIKELY CAUSED BY THE PROCEDURE. THE CRT-D 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 14635260 ↗
• InjuryApr 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D 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 14189831 ↗
• MalfunctionMar 17, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS CONCERNED THEIR HEART RATE WAS LOWER THAN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LOWER PROGRAMMED RATE. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 13794425 ↗
• MalfunctionDec 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DROP IN LONGEVITY WAS DETERMINED TO BE NORMAL BATTERY DEPLETION. THE DEVICE WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920391 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO VEGETATION ON THE LEADS AND AN INFECTION. THE SYSTEM WAS REPLACED WITH A IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD ONLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11967276 ↗