Amplia MRI™ CRT-D SureScan™ DTMB1D1 (UDI 00643169705791)Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00643169705791), received between Jun 6, 2017 and Feb 18, 2025 — classified as 1 death, 52 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (14 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 85 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THE DETECTION OF SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS CLASSIFIED 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 21399756 ↗
• InjuryJan 29, 2025Premature Discharge of Battery; Communication or Transmission Problem; Reset Problem; Premature Discharge of Battery; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A FULL ELECTRICAL RESET AND 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 21264595 ↗
• InjuryJan 7, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT STATED THEY RECEIVED A SHOCK. FOLLOW UP WAS CONDUCTED AND NOTED THAT THE ARRYTHMIA STARTED AS A SUPRA VENTRICULAR TACHYCARDIA (SVT) AND DEVELOPED INTO VENTRICULAR TACHYCARDIA (VT) AND THREE ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) WERE UNSUCCESSFUL, THEREFORE, THE PATIENT RECEIVE TWO SHOCKS AND IT WAS NOTED THAT THE SECOND SHOCK BROKE THE ARRHYTHMIA. IT WAS ALSO NOTED THAT IT WAS NOT ABLE TO BE CONFIRMED NOR DENIED IF THE THERAPY WAS APPROPRIATE. 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 21091935 ↗
• MalfunctionOct 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT BY THE PATIENT "HEARD THE MAGNET TONE BUT THERE ARE NO MAGNETS AROUND ME, THE DEVICE MUST BE MALFUNCTIONING BECAUSE I'M NOT AROUND A MAGNET."  ADDITIONALLY, THE PATIENT INDICATED SEVERAL TIMES THAT THE DEVICE WAS MALFUNCTIONING.  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 20540169 ↗
• MalfunctionSep 20, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS FAR FIELD R-WAVE (FFRW) OVERSENSING, NOISE AND OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO NOTED THERE WAS NOISE ON THE ATRIAL AND VENTRICULAR CHANNELS THAT WAS LIKELY ELECTROMAGNETIC INTERFERENCE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD AND DEVICE 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 20267117 ↗
• InjuryJun 12, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT CAME TO THE FACILITY REPORTING TO HAVE RECEIVED A SHOCK.  THE HEALTHCARE PROFESSIONAL NOTED THAT THE DEVICE MAY HAVE MALFUNCTIONED AND NEEDS TO ASSESS THE FUNCTION OF THE DEVICE THROUGH A DEVICE INTERROGATION.  THE 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 19522735 ↗
• InjuryMar 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE END OF SERVICE (EOS) FROM THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866026 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPLACEMENT PROCEDURE, POCKET EROSION WAS NOTED. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 18013360 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SWELLING AND SIGNS OF ECCHYMOSIS WAS OBSERVED OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SITE. THE CRT-D WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT OVERSENSING AND UNDERSENSING. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ecchymosis; Swelling/ Edema

  MAUDE report 18013338 ↗
• MalfunctionSep 28, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CLINICIAN WAS REPORTING LOW RATES IN THE THIRTIES ON TELEMETRY OVERNIGHT, WHICH IS LOWER THAN THE PROGRAMMED LOWER RATE. 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: Bradycardia

  MAUDE report 17836541 ↗
• InjurySep 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 17682435 ↗
• InjuryJul 18, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AT 32 BEATS PER MINUTE, WHICH WAS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17346780 ↗
• MalfunctionJul 12, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD VENTRICULAR TACHYCARDIA (VT) AND FLUTTERING EPISODES THAT WERE NOT BEING DETECTED BY THE DEVICE. 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 17311803 ↗
• MalfunctionFeb 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD SETSCREW WAS STRIPPED AND COULD NOT BE UNSCREWED USING SEVERAL DIFFERENT WRENCHES. USING A COMBINATION OF SEVERAL DIFFERENT PRODUCTS FROM THE SURGERY DEPARTMENT, THE DOCTOR WAS FINALLY ABLE TO DISASSEMBLE THE HEADER TO THE POINT THAT THEY COULD GRAB THE SCREW AND MANUALLY TURN IT. THE RA LEAD WAS REMOVED, TESTED, AND THEN PUT INTO NEW DEVICE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353830 ↗
• DeathOct 21, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS NOTED THE DEVICE DELIVERED ONE ANTI-TACHYCARDIA PACING SEQUENCE (DURING CHARGING) AND A TOTAL OF SIX SHOCKS FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF). THE DEVICE TRIGGERED SHORT CIRCUIT PROTECTION (SCP) FOR ALL SIX SHOCKS, AS THE SHORT CIRCUIT PROTECTION FEATURE TRUNCATES HIGH-VOLTAGE ENERGY DELIVERY WHEN UNEXPECTED ADDITIONAL CURRENT (DUE TO A SHORT-CIRCUIT IN THE CIRCUITRY) IS DETECTED DURING SHOCK DELIVERY. NONE OF THE SIX SHOCKS DELIVERED CONVERTED THE ARRHYTHMIA. IT WAS SUSPECTED THAT BASED ON THE DEVICE DATA, THE PATIENT HAD PASSED AWAY GIVEN THE SUSTAINED ARRHYTHMIA. IT WAS LATER IDENTIFIED BASED ON AN INTERNET SEARCH THAT THE PATIENT PASSED AWAY ON THE SAME DAY OF THE EPISODES. ADDITIONAL INFORMATION OBTAINED NOTED ON THE DAY OF THE REPORTED EPISODE, THE PATIENT WAS EXPERIENCING NAUSEA, DIAPHORESIS, AND CHEST CRAMPING. THE PATIENT WAS FOUND DECEASED THE NEXT DAY AFTER FAILING TO ANSWER THEIR PHONE. EMERGENCY RESPONDERS AND PHYSICIANS INVOLVED WITH THE CASE SUSPECTED THE DEATH TO BE A RESULT OF A ¿MASSIVE¿ MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Ventricular Fibrillation

  MAUDE report 15654852 ↗
• InjurySep 7, 2022Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AN EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT) INAPPROPRIATELY AND DID NOT DELIVER THE EXPECTED HIGH VOLTAGE THERAPY. 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 15373929 ↗
• InjuryAug 22, 2022Premature 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 AND HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271709 ↗
• InjuryJun 21, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MOVING IN THE POCKET. IT WAS NOTED THAT THERE WAS VISIBLE MOVEMENT OF THE DEVICE WITH POSITIONAL CHANGES. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 14756982 ↗
• MalfunctionFeb 21, 2022Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR AN EPISODE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). AFTER THE FIRST THERAPY WAS DELIVERED, IT APPEARS THAT THE RHYTHM WAS IN A ONE TO ONE RHYTHM WITH THE ATRIAL EVENT OCCURRING FIRST. THE DEVICE DELIVERED ANOTHER ROUND OF ATP AS IT STILL CLASSIFIED AS A VT EPISODE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 13568585 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13192399 ↗
• MalfunctionDec 13, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ABOUT A MONTH LEFT AND HAD ONLY BEEN IMPLANTED FIVE YEARS. 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 12983566 ↗
• InjuryDec 7, 2021Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CLINICIAN BELIEVED THE DEVICE INAPPROPRIATELY WITHHELD THERAPY IN A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. A REVIEW OF THE TRANSMISSION SHOWED THE DEVICE FEATURE, THAT IS DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THERE'S A SENSED 1:1 ATRIAL TO VENTRICULAR CONDUCTION OF RHYTHMS THAT EXHIBIT A GRADUAL INCREASE IN RATE INTO THE DETECTION ZONE, INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT). 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: Tachycardia

  MAUDE report 12953616 ↗
• InjuryNov 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT WAS DIAGNOSED WITH CORONAVIRUS DISEASE 2019.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 12841092 ↗
• InjuryAug 16, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS AND LOW IMPEDANCE WHICH RESULTED IN POTENTIAL PREMATURE DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY. THE LEAD WAS CAPPED AND REPLACED. 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 12324994 ↗
• InjuryAug 13, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319185 ↗