Amplia MRI™ CRT-D SureScan™ DTMB1D1 (UDI 00643169929616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169929616), received between Jul 12, 2018 and Feb 16, 2026 — classified as 13 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THE INFECTION WAS DETERMINED TO BE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND THE PATIENT WAS GIVEN VANCOMYCIN. THE PATIENT EXPERIENCED A WOUND OVER THE DEVICE SITE WITH DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A LEADLESS PACEMAKER WAS IMPLANTED 4 DAYS LATER AND THE PATIENT HAD BEEN IN BRADYCARDIA SINCE EXPLANT.

  Patient problems: Bradycardia; Drug Resistant Bacterial Infection; Fluid Discharge; Medical device site infection; Wound Dehiscence

  MAUDE report 24349182 ↗
• InjuryOct 27, 2025Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AND INAPPROPRIATE ATRIAL PACING AT TIMES. IT WAS ALSO NOTED THAT ALL ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THERAPIES HAD BEEN DISABLED DUE TO AN ATRIAL LEAD POSITION CHECK FAILURE. IN ADDITION; A CHARGE CIRCUIT TIMEOUT HAD OCCURRED AS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT END OF SERVICE (EOS). IT WAS ALSO NOTED THAT THE DEVICE TRIGGERED AN ALERT FOR LONG CHARGE TIME POST RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS PROGRAMMED OFF. THE CRT-D AND RA LEAD REMAIN IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND IS NOW HOME ON HOSPICE. THE PATIENT HAS DECLINED ANY ADDITIONAL INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392205 ↗
• InjuryOct 9, 2024Premature 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 20410247 ↗
• MalfunctionJan 11, 2024Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT "I HAVE SOME CONCERNS ABUT THE BATTERY LIFE.  IS IT NORMAL FOR IT TO BE AT TWO YEARS FOR THE PAST THREE YEARS? THE CLINIC DOES NOT WANT TO TALK ABOUT THE BATTERY STATUS AND EVEN MENTIONED THEY SHOULD TURN IT OFF. I FIND THAT STRANGE AND I AM CONCERNED ABOUT MY DEVICE FUNCTION."  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 18498153 ↗
• InjuryJun 9, 2022Premature Discharge of Battery; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD BEEN WORKING ON THEIR CAR AND WHEN THEY STUCK THEIR PLIERS ON THE ENGINES ELECTRODE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOCKED THE PATIENT AND SUBSEQUENT DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS OBSERVED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A PREVIOUSLY REPORTED GRADUAL INCREASE IN IMPEDANCE, AND A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO OVERSENSING, SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. FOLLOWING THE SHOCKS, THE DEVICE WAS INTERROGATED AND A LARGE INCREASE IN THE RV BIPOLAR IMPEDANCE WAS OBSERVED, ALONG WITH HIGH RV DEFIBRILLATION IMPEDANCE. IT WAS ADDED THAT ALL DELIVERED ENERGY AMOUNTS FOR THE SHOCKS WERE NOT THE PROGRAMMED AMOUNTS. THE DEVICE AND RV LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 14644241 ↗
• MalfunctionNov 23, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PARTIAL POWER ON RESET (POR), WHICH OCCURRED AT THE BEGINNING OF THE INTERROGATION. 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 10884903 ↗
• InjurySep 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED PREMATURE BATTERY DEPLETION POSSIBLY DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. 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 Consequences Or Impact To Patient

  MAUDE report 10600829 ↗
• InjuryJun 9, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELAYED ARRHYTHMIA TERMINATION AFTER A SHOCK FOR VENTRICULAR FIBRILLATION (VF). THE DELAY IN TERMINATION RESULTED IN REDETECTION AND ANOTHER SHOCK WHICH REINITIATED THE ARRHYTHMIA. THE EPISODE WAS ULTIMATELY TERMINATED WITH ANOTHER SHOCK. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDERSENSING DURING VENTRICULAR ARRHYTHMIAS. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 10132391 ↗
• InjuryDec 17, 2019Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481262 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED AND NOT REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 9418398 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8731867 ↗
• InjuryMay 7, 2019Adverse 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, CONFIRMED WITH POSITIVE CULTURES OF THE POCKET. BLOOD CULTURES WERE NEGATIVE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND THE LEADS WERE CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8587832 ↗
• MalfunctionFeb 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE BATTERY VOLTAGE WAS STILL BELOW THE LEVEL INDICATED FOR IMPLANT AFTER THE DEVICE WAS AT ROOM TEMPERATURE FOR 4 DAYS. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8315677 ↗
• MalfunctionNov 14, 2018High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD ISSUES TIGHTENING THE SETSCREW ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PACING IMPEDANCES ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE HIGH AND UNDEFINED. THE PHYSICIAN REMOVED THE LEADS AND REASSESSED THE CONNECTIONS, BUT THE IMPEDANCES WERE STILL HIGH AND UNDEFINED. BOTH LEADS WERE THEN CHECK THOUGH THE ANALYZER AND THEY WERE NORMAL. THE PHYSICIAN THEN REMOVED THE CRT-D DEVICE AND IMPLANTED A NEW DEVICE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071028 ↗
• InjuryOct 4, 2018Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7936137 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION AND HAD THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXPLANTED. IT WAS ALSO NOTED THAT THE PATIENT HAD A PERSISTENT LEFT SUPERIOR VENA CAVA (SVC). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7856569 ↗
• InjuryAug 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET HEMATOMA POST IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). HEMATOMA WAS EVALUATED WITH NO ISSUES OR COMPLICATIONS. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2018-08-28 ADDITIONAL INFORMATION RECEIVED NOTED APPROXIMATELY TWO WEEK LATER, SURGICAL INTERVENTION WAS DONE TO TREAT THE HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 7822856 ↗
• MalfunctionJul 12, 2018Device Displays Incorrect Message; Battery Problem; Power Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS REPORTED THAT DURING A PRE-IMPLANT INTERROGATION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POWER ON RESET (POR) AND WAS DISPLAYING END OF SERVICE (EOS). THE CRT-D WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7684010 ↗