Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1 (UDI 00643169705784)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00643169705784), received between Apr 6, 2017 and May 9, 2025 — classified as 2 deaths, 42 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (8 reports).

3 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-1306-2021 · 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-0582-2018 · Root cause: Process design · Recall details · FDA record ↗

3. Dec 9, 2016Class IITerminated

   During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

   Z-0962-2017 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED, AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED. THE REASON FOR EXPLANT AND REPLACEMENT WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994997 ↗
• InjuryMar 3, 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 REMOVED DUE TO AN INFECTION. THE ORGANISM OF THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 21506346 ↗
• MalfunctionNov 5, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED, THAT ELECTROMAGNETIC INTERFERENCE(EMI) WAS OBSERVED, ON BOTH ATRIAL AND VENTRICULAR CHANNELS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 20612261 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT EXPERIENCED SKIN EROSION. AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS VISIBLE THROUGH THE SKIN. THE DEVICE WAS REMOVED. AND THE ALL THE LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 19829187 ↗
• MalfunctionJul 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321927 ↗
• MalfunctionOct 1, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED ON ELECTROGRAMS (EGM) DUE TO SUSPECTED WEAK TELEMETRY OR TELEMETRY DROP OUT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524120 ↗
• MalfunctionSep 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH. IT WAS SUSPECTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS MALFUNCTIONING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 15418690 ↗
• InjuryAug 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 15202381 ↗
• InjuryJun 21, 2022Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POSSIBLY RECEIVED ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THE CLINICIAN SUSPECTED LOSS OF CAPTURE DUE TO SEEING A HEART RATE IN THE 30S ON TELEMETRY. RAPID RESPONSE WAS CALLED. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 14753122 ↗
• DeathDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT IMPLANTED WITH A DEVICE UNDER AN ADVISORY NOTING THE POTENTIAL FOR INTERNAL DEVICE ARCING DURING HIGH-VOLTAGE CHARGING EXPIRED. FOLLOW-UP WAS ATTEMPTED TO DETERMINE THE CAUSE OF DEATH OR IF A DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER NO INFORMATION COULD BE OBTAINED.

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

  MAUDE report 12937226 ↗
• InjuryOct 29, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DELETION.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12722358 ↗
• InjuryAug 20, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER BREAST RECONSTRUCTION SURGERY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MOVED AND WAS UNCOMFORTABLE FOR THE PATIENT. THE DEVICE WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 12348678 ↗
• InjuryJul 22, 2021Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem; Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPROGRAMMED.

  Patient problems: Tachycardia

  MAUDE report 12211496 ↗
• InjuryJun 17, 2021Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE ONSET DISCRIMINATOR OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE WITHHELD THERAPY AND DETECTION DURING A VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) EPISODE. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AT THE TIME. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Tachycardia; Ventricular Fibrillation

  MAUDE report 12016598 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION IN THE POCKET AREA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12009917 ↗
• MalfunctionMar 31, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS DISCLOSED BY THE CLINIC THAT THE DEVICE WAS CHECK AT FOLLOW-UP. THE DEVICE FUNCTION WAS NORMAL. NO ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598770 ↗
• InjuryMar 26, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A POSSIBLE EARLY 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 11575128 ↗
• MalfunctionMar 16, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ESTIMATED BATTERY LIFE OF FIVE YEARS SEEMED LOW. 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 11495184 ↗
• MalfunctionJan 26, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED AN ELECTRICAL RESET DURING INTERROGATION. 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 11229642 ↗
• InjuryJan 25, 2021Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS ALSO REPORTED BY THE PATIENT THERE WAS A PREVIOUS VISIT TO THE EMERGENCY ROOM AND PHYSICIAN ASK IF THE PATIENT WANTED THE DEVICE SHUT OFF BECAUSE IT SERVES HIM TO USE. THE DEVICE WAS TURNED OFF AND THE PATIENT INQUIRED IF THE DEVICE WERE TO BE REMOVED WOULD IT HELP PAIN FROM THE PATIENT'S NEUROPATHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222776 ↗
• InjuryJan 14, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE NOTED THAT THE SHOCKS WERE APPROPRIATE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11170314 ↗
• InjuryOct 16, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND HAD GONE FROM THE RECOMMENDED REPLACEMENT TIME (RRT) TO END OF SERVICE (EOS) IN A VERY SHORT PERIOD OF TIME. ALL FUNCTION WAS NOTED TO HAVE BEEN LOST AND THE PACING DEPENDENT PATIENT WAS EXPERIENCING BRADYCARDIA. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 10692028 ↗
• InjuryOct 15, 2020Inappropriate/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 DELIVERED FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, WHICH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR FIBRILLATION. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10683805 ↗
• MalfunctionOct 9, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PARTIAL ELECTRICAL RESET UPON INTERROGATION. THERE WERE NO POWER ON RESET (POR) PARAMETER CHANGES. THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656182 ↗
• InjuryOct 7, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), A POWER ON RESET (POR) OCCURRED IN INITIAL INTERROGATION. THE RESET WAS CLEARED. THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10643403 ↗