Amplia MRI™ CRT-D SureScan™ DTMB1D4 (UDI 00643169929623)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169929623), received between Aug 9, 2017 and Mar 6, 2025 — classified as 33 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (7 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT WAS HOSPITALIZED AND EXPERIENCING CHEST PAIN. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 21540347 ↗
• InjuryAug 28, 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), RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED, AND BOTH LEFT VENTRICULAR (LV) LEADS WERE CAPPED DUE TO A FUNGAL INFECTION WITH SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fungal Infection; Sepsis

  MAUDE report 20087169 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT ATRIAL (RA) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AN INFECTION OCCURRED.  THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS WITH BACTEREMIA NOTED.  THE RA LEAD WAS EXPLANTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection

  MAUDE report 18364232 ↗
• MalfunctionNov 3, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. 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 18069620 ↗
• InjuryAug 24, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT RECEIVED A SHOCK FOR A RHYTHM DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE AN ATRIAL ARRYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR). ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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); Syncope/Fainting

  MAUDE report 17612546 ↗
• MalfunctionDec 6, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED BY THE PATIENT THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT HAS CONCERNS ABOUT THE CRT-D AND ITS OPERATING STATUS. THE PATIENT INDICATED WHILE CARRYING A HEAVY POWER BANK IT CAME WITHIN ONE FOOT OF THE IMPLANT "FOR A SECOND" AND THE PATIENT INDICATED "EXPERIENCED SOMETHING". THE PATIENT IS WORRIED THE IMPLANT WAS INTERFERED WITH AND MAY HAVE TURNED OFF AND WANTED CONFIRMATION THE IMPLANT IS STILL FUNCTIONING. FURTHERMORE, THE PATIENT INDICATED ATTEMPT TO DOWNLOAD THE APP AND AFTER A FEW MINUTES THE APP SAID "DEVICE NOT FOUND" WHICH WORRIED THE PATIENT. UPON LEARNING THE CRT-D IS NOT COMPATIBLE WITH THE APP, THE PATIENT DISCUSSED IT WOULD BE LESS CONFUSING IF THE APP SIMPLY ADDRESSED THAT THE IMPLANT IS NOT COMPATIBLE INSTEAD OF SAYING "NOT FOUND". THE PATIENT WAS REFERRED TO THE PHYSICIAN. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15923802 ↗
• InjuryOct 31, 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 WITH SUSPECTED VEGETATION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15700559 ↗
• MalfunctionAug 19, 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 PATIENT EXPERIENCED A SHOCK FROM A POWER CORD AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STARTED EMITTING AN ALERT TONE. THERE WAS A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT V-V INTERVALS FROM EXTERNAL NOISE THAT WAS CONSISTENT WITH THE EXTERNAL SHOCK. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Electric Shock

  MAUDE report 15259970 ↗
• InjuryApr 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 14143036 ↗
• InjuryMar 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE 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 13763958 ↗
• MalfunctionDec 8, 2021Pacing Problem; Device-Device Incompatibility; Pacing Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS ONE HUNDRED PERCENT PACED UNTIL A MAGNETIC RESONANCE IMAGING (MRI) WAS DONE AND NOW THERE ARE NO PACING SPIKES. THE CLINICIAN WAS CONCERNED IF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FUNCTIONING APPROPRIATELY. 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 12962529 ↗
• MalfunctionOct 26, 2021Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  ADDITIONAL INFORMATION RECEIVED INDICATED ELECTROMAGNETIC INTERFERENCE WAS CONFIRMED. THE PATIENT WAS USING AN OLD LAWNMOWER AT THE SAME TIME AS THE SHORT V-V EPISODE. THERE WAS NO ISSUE WITH THE LEADS AND FUNCTION HAS REMAINED NORMAL. NO REPROGRAMMING OR INTERVENTION WAS DONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698070 ↗
• InjuryJul 28, 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 REMOVED DUE TO INFECTION. THE PATIENT RECEIVED A NEW SYSTEM THE FOLLOWING WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12240273 ↗
• InjuryJul 1, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE HIS LEAD EXHIBITED HIGH THRESHOLDS. THE 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 12103620 ↗
• InjuryJun 14, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE 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 11991203 ↗
• InjuryMay 21, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THE DEVICE DETECTED AS FAST VENTRICULAR TACHYCARDIA. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND IT WAS DISCOVERED THAT THE PATIENT HAD BEEN TAKING A LOWER DOSAGE OF THEIR PRESCRIBED MEDICATION. THEIR MEDICATIONS WERE ADJUSTED IN ORDER TO CONTROL THEIR AF. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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: Shock from Patient Lead(s)

  MAUDE report 11863021 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET REVISION WAS PERFORMED BECAUSE THE PHYSICIAN WAS CONCERNED ABOUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ERODING. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 11855936 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE ORGANISM WAS IDENTIFIED AS (B)(6). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11737243 ↗
• MalfunctionApr 19, 2021Data Problem; Data Problem

  IT WAS LATER REPORTED THAT THE LONGEVITY ESTIMATE IS BEING CALCULATED USING BATTERY VOLTAGE MODEL ONLY. BY USING THIS MODEL THE BATTERY ESTIMATE IS NOT EXPECTED TOO CHANGE MUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685632 ↗
• MalfunctionJan 20, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT DURING INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A POWER ON RESET (POR) OCCURRED. 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 11201891 ↗
• InjuryNov 4, 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 FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, WHICH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 10787881 ↗
• MalfunctionOct 1, 2020Appropriate 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 SUSPECTED TO NOT BE FUNCTIONING AS PROGRAMED. A LOSS OF CAPTURE WAS ALSO REPORTED, MORE SPECIFICALLY THAT CAPTURE BY THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE DISCERNED. THE CRT-D AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10611964 ↗
• InjuryJun 26, 2020Failure 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) INCORRECTLY CLASSIFIED THREE VENTRICULAR TACHYCARDIA (VT) EPISODES AS SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES AND INAPPROPRIATELY WITHHELD THERAPY. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 10201663 ↗
• MalfunctionJun 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE CLINICIAN THAT THE LONGEVITY ESTIMATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS LOWER THAN EXPECTED. THE DEVICE 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 10134763 ↗
• InjuryApr 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS CHRONICALLY HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD WITH INTERMITTENT CAPTURE. IT WAS NOTED THIS LEAD TO PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 Known Impact Or Consequence To Patient

  MAUDE report 9982661 ↗