Amplia MRI™ CRT-D SureScan™ DTMB1D4 (UDI 00643169543430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00643169543430), received between Dec 9, 2016 and Sep 9, 2024 — classified as 4 deaths, 81 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (28 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 122 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO HAVING A LOW HEART RATE. IT WAS NOTED THAT THERE WAS NO PACING FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A TEMPORARY PACEMAKER AND LEAD WERE USED FOR PACING SUPPORT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND THE CRT-D WAS UNABLE TO ESTABLISH TELEMETRY WITH THE MONITOR AND IT WAS NOT ABLE TO BE INTERROGATED. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 20170792 ↗
• InjuryAug 6, 2024Adverse 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) GENERATOR CHANGE PROCEDURE. UPON OPENING THE POCKET, PUS WAS DISCOVERED FOR UNKNOWN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 19919685 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION, SEPSIS, AND EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Sepsis; Unspecified Infection

  MAUDE report 18132200 ↗
• InjuryOct 31, 2023Signal Artifact/Noise; Electromagnetic Interference; Device Sensing Problem; Signal Artifact/Noise; Electromagnetic Interference; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER A SYNCOPAL EPISODE. AN INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INDICATED POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) NOISE ON THE ATRIAL CHANNEL, RESULTING IN OVERSENSING AND DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 18040090 ↗
• InjurySep 8, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS IN A DYSSYNCHRONOUS RHYTHM AND THERAPIES WERE WITHHELD FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE THAT IS DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THERE IS SENSED 1:1 ATRIAL TO VENTRICULAR CONDUCTION OF RHYTHMS THAT EXHIBIT A GRADUAL INCREASE IN RATE INTO THE DETECTION ZONE AND THE ARRYTHMIA SPONTANEOUSLY TERMINATED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Tachycardia

  MAUDE report 17710890 ↗
• InjurySep 1, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANTED SEVERAL YEARS AGO AND IT WAS CURRENTLY "STUCK IN THEIR ARMPIT." THE PATIENT NOTED IT WAS THE "WORST SURGERY OF THEIR LIFE." AT THIS TIME, 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 17673781 ↗
• InjuryJul 17, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS FOUND TO BE BRADYCARDIC ON OVERNIGHT TELEMETRY, DOWN TO THIRTIES BUT WITH POSITIVE RESPONSE UPON AWAKENING. ON REVIEW OF TELEMETRY IN THE MORNING, NO TRUE BRADYCARDIA WAS NOTED. THE PATIENT WILL CONTINUE TO BE FOLLOWED VIA REMOTE MONITORING.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 17335803 ↗
• MalfunctionJun 21, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN.  IT WAS ALSO REPORTED THAT THE PATIENT STATED "FEELS LIKE THE DEVICE MOVED".  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: Chest Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17174932 ↗
• MalfunctionApr 11, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED RAPID BATTERY DEPLETION. 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 16718584 ↗
• MalfunctionMar 27, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT, THE PHYSICIAN HAD DIFFICULTY ENGAGING THE SCREW WITH THE WRENCH. THE PHYSICIAN REMOVED THE GROMMET TO VISUALIZE THE SCREW, AND WAS THEN ABLE TO ENGAGE THE SCREW WITH THE WRENCH. THE DEVICE WAS ABLE TO BE 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 16619442 ↗
• InjuryFeb 22, 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 16417579 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SMALL FALL AND NOTICED PAIN AND SWELLING AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. IT WAS DETERMINED THAT THE PATIENT WAS EXPERIENCING CELLULITIS AND A SKIN INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.  IT WAS NOTED THAT THE PATIENT DID NOT TAKE THE ANTIBIOTICS. THERE WAS INCREASED REDNESS AT THE CRT-D IMPLANT SITE AND AN OBJECT STICKING OUT OF THE SITE. THE PATIENT CUT OFF THE OBJECT , THINKING THAT IT WAS A SUTURE, BECAUSE IT WAS GETTING CAUGHT ON THEIR SHIRT AND OCCASIONALLY CAUSED BLEEDING. THE PATIENT EXPERIENCED A POCKET INFECTION AND WAS ADMINISTERED ORAL AND INTRAVENOUS ANTIBIOTICS. IT WAS NOTED THAT THE POCKET INFECTION WAS MORE SUPERFICIAL THAN DEEP. A POCKET REVISION WAS PERFORMED AND THE CRT-D REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis; Erythema; Fall; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15996294 ↗
• MalfunctionNov 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT MENTIONED THE BATTERY IS DEPLETING FASTER THAN IT SHOULD. 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 15848114 ↗
• InjuryJul 20, 2022Adverse 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) SYSTEM WAS EXPLANTED DUE TO INFECTION AND ENDOCARDITIS. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 15069651 ↗
• InjuryJul 5, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A HEALTHCARE PROFESSIONAL BELIEVES THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE "MISFIRED" TWICE. THE REMOTE MONITOR TRANSMISSION WAS ALSO UNABLE TO BE SENT THROUGH THE MOBILE PROGRAMMER TABLET. 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 14915178 ↗
• InjuryJul 1, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT SHOULD HAVE BEEN DETECTED AS A VENTRICULAR TACHYCARDIA (VT).  IT WAS ALSO NOTED THAT DURING USE OF THE RIGHT ATRIAL (RA) LEAD INTERMITTENT UNDERSENSING WAS NOTED ON SOME STORED ELECTROGRAM (EGMS) EPISODES.  THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 14886072 ↗
• MalfunctionMay 20, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ONLY HAD A GIVEN AMOUNT OF REMAINING LONGEVITY. 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 14463511 ↗
• InjuryApr 25, 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 14194009 ↗
• InjuryApr 6, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS A POSSIBLE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE DEVICE 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 14022493 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND EROSION OF THE ABANDONED LEADS FROM A PREVIOUS DEVICE SYSTEM. THE ABANDONED LEADS AND ACTIVE LEADS WERE ALL CUT AT THE TISSUE AND PARTIALLY REMOVED. THE LEAD BODIES REMAIN IN THE PATIENT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED BY A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 13524982 ↗
• InjuryJan 6, 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) WAS NOT FUNCTIONING AS EXPECTED. 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 13177136 ↗
• InjuryDec 30, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, CHRONIC THRESHOLDS WHICH RESULTED IN ACCELERATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE LV LEAD EXHIBITED PHRENIC NERVE AND DIAPHRAGMATIC STIMULATION. THE LV LEAD WAS CAPPED AND REPLACED. 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 13118495 ↗
• InjuryDec 9, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  TACHYCARDIA DETECTION ZONES WERE REPROGRAMMED. IT WAS NOTED AT THAT TIME THAT THE DEVICE HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS SHORTLY THEREAFTER EXPLANTED AND REPLACED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12968880 ↗
• InjuryNov 17, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND HIGH LEFT VENTRICULAR (LV) LEAD OUTPUTS WERE NOTED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LV 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 12829027 ↗
• InjuryNov 15, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 12814201 ↗