Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1 (UDI 00763000059682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00763000059682), received between Apr 25, 2018 and Sep 9, 2025 — classified as 1 death, 36 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (15 reports).

1 FDA recall record 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. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1763-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 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 EXPLANTED AND REPLACED SEVERAL DAYS LATER DUE TO INFECTION AND BACTEREMIA. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection

  MAUDE report 23000202 ↗
• MalfunctionJan 2, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE OVERSENSING WAS DETERMINED TO BE ELECTROMAGNETIC INTERFERENCE OVERSENSING AND NO INTERVENTION WAS PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WELDS REGULARLY. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053522 ↗
• InjuryNov 22, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CORRECTLY DETECTED VENTRICULAR TACHYCARDIA (VT) BUT SHORT CIRCUIT PROTECTION WAS TRIGGERED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED. IT WAS NOTED THAT THE CRT-D ATTEMPTED TO DELIVER THE HIGH VOLTAGE ENERGY TWICE, AND EACH TIME LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUBSEQUENTLY EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR (RV) 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 20764111 ↗
• InjuryOct 28, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS DONE TO DECREASE THE DETECTION RATE, INCREASE THE VENTRICULAR BLANKING, AND A LEAD FROM THE CARDIAC CONTRACTILITY MODULATION THERAPY SYSTEM WAS TURNED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545187 ↗
• MalfunctionSep 20, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BOX WAS OPEN, WITH P ARTIALLY SEALED PLASTIC AND PLASTIC SEAL STILL IN PLACE. THE CONTENTS OF THE BOX INCLUDING THE CRT-D WERE NOTED TO BE WET. THE DEVICE WAS NOT IMPLANTED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268875 ↗
• InjurySep 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT THE PATIENT CAME IN FOR PLASTICS WITH THE DEVICE TO BE PUT SUBMUSCULAR, BUT THE POCKET HAD AN INFECTION WITH PURULENT DISCHARGE. 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 20219024 ↗
• InjuryJul 26, 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) SYSTEM WAS EXPLANTED DUE TO INFECTION.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19839892 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CARDIAC ARREST. INFORMATION REGARDING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLA TOR (CRT-D) FUNCTION AT THE TIME OF THE ARREST WAS REQUESTED BUT NOT RECEIVED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 19638914 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DISCOVERED VEGETATION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM LEADS. THE PATIENT RECEIVED ANTIBIOTICS. THE CRT-D SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Respiratory Failure; Unspecified Infection

  MAUDE report 19602023 ↗
• MalfunctionMay 9, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277235 ↗
• MalfunctionApr 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A GRAY BAR INDICATING BATTERY VOLTAGE BELOW INDICATION FOR IMPLANT. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169249 ↗
• MalfunctionApr 10, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERE WERE MULTIPLE HIGH RATE NON-SUSTAINED (HRNS) EPISODES NOTED.  IT WAS ALSO NOTED THAT THE ELECTROGRAMS (EGM) SIGNAL FOR THE COMPETITOR RIGHT VENTRICULAR LEAD COIL TO CAN COULD BE MYOPOTENTIALS OR ELECTROMAGNETIC INTERFERENCE (EMI).  ADDITIONALLY, IT WAS NOTED HAVING VENTRICULAR SENSING EGM MARKERS WHILE NOISE IS VISIBLE ON THE COMPETITOR RIGHT VENTRICULAR LEAD COIL TO CAN COULD ALSO BE EXPLAINED BY EMI OR POTENTIALLY A COMPETITOR LEAD ISSUE BUT, COULD NOT BE CONFIRMED.  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 19080573 ↗
• MalfunctionFeb 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED PRIOR TO USE, AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691829 ↗
• InjuryFeb 7, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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 18660202 ↗
• MalfunctionJan 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582947 ↗
• InjuryJan 9, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), A PATIENT REPRESENTATIVE INDICATED ¿THE DOCTOR SAID IT HAD TWO YEARS OF BATTERY LEFT AFTER ONE MONTH.  A REPRESENTATIVE MADE SOME ADJUSTMENTS TO IMPROVE BATTERY LONGEVITY AND THE PATIENT WAS TOLD TO SHUT OFF THE BEDSIDE MONITOR AS THE DEVICE WAS CONSTANTLY SEARCHING AND DRAINING THE BATTERY. AT A FOLLOW UP VISIT THE DOCTOR MADE MORE ADJUSTMENTS AND THE BATTERY LIFE IS NOW UP TO THREE YEARS.¿  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 18474909 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT A BISCUIT-SIZED BUMP HAD DEVELOPED AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE, AND THERE WAS REDNESS AND SWELLING AT THE SITE. IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED AN INFECTION AND THE CRT-D SYSTEM WAS EXPLANTED. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 18410866 ↗
• MalfunctionDec 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377941 ↗
• InjuryDec 19, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DID HAVE A DEVICE CHECK AFTER THE REPORTED EVENT. THE SHOCK WAS APPROPRIATE AND THE DEVICE PACING BELOW THE PROGRAMMED RATE WAS NOT CONFIRMED. THE PATIENT¿S THRESHOLDS ARE VARIABLE ON THE LV LEAD. NO REPROGRAMMING OR INTERVENTION WAS DONE.

  Patient problems: Bradycardia; Shock from Patient Lead(s)

  MAUDE report 18356289 ↗
• InjuryOct 23, 2023Adverse 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 INFECTION ANAEROBIC COCCAL BACTEREMIA AND VEGETATION NOTED ON THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 17990242 ↗
• InjurySep 27, 2023Adverse 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 AND THE DEVICE ERODING THROUGH THE PATIENT'S SKIN. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 17826211 ↗
• MalfunctionAug 24, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO DIZZINESS. IT WAS NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO ELECTROMAGNETIC INTERFERENCE. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED A HIGH THRESHOLD MEASUREMENT. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 17610518 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PATIENT EXPERIENCED DISCOMFORT, PAIN, REDNESS, AND SWELLING. THE DIAGNOSIS WAS INFECTION/ENDOCARDITIS. THE DEVICE AND LEADS WERE EXPLANTED. ANTIBIOTIC TREATMENT WAS REQUIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Endocarditis; Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17481280 ↗
• DeathJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PERHAPS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FAILING WHEN THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 17303224 ↗
• MalfunctionMar 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526518 ↗