Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1 (UDI 00643169837683)Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00643169837683), received between Sep 5, 2018 and Aug 24, 2026 — classified as 1 death, 42 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (17 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 78 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) inappropriately withheld therapy for events that were misclassified as Ventricular Fibrillation (VF) by the Atrial Flutter (AF) by the device discriminator. The device discriminator was turned off. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419005 ↗
• MalfunctionJul 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE PATIENT WAS SEEN IN CLINIC AND NO PRODUCT ISSUES WERE OBSERVED, THE PHYSICIAN NOTED THAT THE LIA WAS NOT OF CONCERN AS IT WAS TRIGGERED DUE TO THE PATIENT PLUGGING IN A DRYER THAT HAS A LIKELY SHORT. THE CRTD 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 25734802 ↗
• MalfunctionSep 17, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE. THE CRTD 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 23070659 ↗
• MalfunctionAug 12, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE PATIENT EXPERIENCED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY DUE TO THE DEVICE MIS DETECTION OF VENTRICULAR TACHYCARDIA (VT). 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 22787066 ↗
• InjuryJun 30, 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 EXTRACTED DUE TO A SYSTEMIC INFECTION. A NEW SYSTEM WAS IMPLANTED FIVE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22357225 ↗
• InjuryMay 9, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS 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 21997510 ↗
• InjuryApr 25, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PACEMAKER MEDIATED TACHYCARDIA (PMT). THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 21910820 ↗
• MalfunctionNov 13, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS FURTHER REPORTED THAT A REMOTE TRANSMISSION WAS RECEIVED FOR REVIEW AND IT WAS DETERMINED THAT THE PATIENT SYMPTOMS WERE UNRELATED TO THE DEVICE SYSTEM. NO INTERVENTION WAS NEEDED.

  Patient problems: Paresthesia

  MAUDE report 20678145 ↗
• InjuryOct 17, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT) BUT THE DEVICE WITHHELD DETECTION DUE TO THE SUPRA VENTRICULAR TACHYCARDIA (SVT)-ONSET DISCRIMINATOR. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 20474113 ↗
• InjuryAug 27, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

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

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20082273 ↗
• MalfunctionJan 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND LOW BLOOD PRESSURE. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY DEPARTMENT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AS THEY BELIEVED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT TREAT THEIR HEART. IT WAS NOTED THAT THERE WAS NO INDICATION THAT ANYTHING HAPPENED WITH THE CRT-D WHEN THE PATIENT WENT TO THEIR HEART CLINIC APPROXIMATELY TWO WEEKS LATER. THE CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 18581631 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DISCOMFORT AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET AFTER LOSING WEIGHT. THE POCKET WAS NOTED TO BE IRRITATED DUE TO THE LEADS UNDER THE SKIN. THE POCKET WAS REOPENED, THE LEADS WERE COILED AROUND THE CRT-D, AND THE SYSTEM WAS REIMPLANTED IN A DEEPER POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 17584395 ↗
• InjuryNov 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT 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 15770337 ↗
• InjuryAug 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD MEASUREMENTS, WHICH CAUSED A SHORTER THAN EXPECTED BATTERY LIFE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD WAS TURNED OFF TO CONSERVE THE BATTERY. WHEN THE BATTERY DIED, THE LEAD WAS CAPPED AND NOT 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 15222824 ↗
• MalfunctionJul 18, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEPLETING FASTER THAN EXPECTED. 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 15041153 ↗
• InjuryFeb 10, 2022Inappropriate/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 ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT).  IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD UNDERSENSING.  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 13509420 ↗
• InjuryJan 12, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT BEGAN TO FEEL AN IRREGULAR HEART BEAT AND LIGHTHEADED AS THOUGH THEY WERE GOING TO FAINT. THE PATIENT SAT DOWN AND FELT A SHOCK FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PATIENT LATER PRESENTED AND WAS ADMITTED TO THE HOSPITAL. THE SHOCK WAS DETERMINED TO BE INAPPROPRIATE. AN ELECTROCARDIOGRAM (ECG) SHOWED NORMAL SINUS RHYTHM WITH OCCASIONAL PREMATURE VENTRICULAR CONTRACTIONS AND BLOODWORK SHOWED HIGH TROPONIN LEVELS. MEDICATION WAS ADMINISTERED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. 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: Arrhythmia; Dizziness; Shock from Patient Lead(s)

  MAUDE report 13235017 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM NOT FEELING WELL AND WITH SWELLING OVER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET. IT WAS DETERMINED THAT THE PATIENT COULD HAVE AN ACTIVE INFECTION AND THE CRT-D SYSTEM WAS EXPLANTED. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. ANTIBIOTIC TREATMENT WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13118808 ↗
• MalfunctionNov 7, 2021Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIPPED A LEAD INTEGRITY ALERT. THERE WAS OVERSENSING DUE TO APPARENT 60HZ ELECTROMAGNETIC INTERFERENCE. 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 12759073 ↗
• InjuryJul 15, 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 EXPLANTED DUE TO AN INFECTION AND REPLACED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12178257 ↗
• InjuryJul 6, 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 EXPLANTED DUE TO AN INFECTION AND VEGETATION ON THE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12121301 ↗
• InjuryJun 21, 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 EXPLANTED DUE TO INFECTION AND EROSION. DURING EXPLANT IT WAS NOTED THAT THERE WAS PUSS IN THE DEVICE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Pocket Erosion; Unspecified Infection

  MAUDE report 12033181 ↗
• MalfunctionMay 17, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT BRIEF RUNS OF VENTRICULAR TACHYCARDIA (VT) WERE OBSERVED ON A TELEMETRY MONITOR AND THE CLINICIAN SUSPECTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FUNCTIONING ABNORMALLY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832255 ↗
• MalfunctionMay 5, 2021Electrical /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. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780830 ↗
• MalfunctionApr 9, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD CONCERNS ABOUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DEGRADATION. THE PATIENT NOTED THAT MOST RECENT LONGEVITY ESTIMATION THEY RECEIVED SEEMED "LIKE A SHORTENED 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 11641027 ↗