Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ (UDI 00643169720671)Recalls & reported problems

Summary

The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 00643169720671), received between Apr 10, 2018 and Sep 9, 2026 — classified as 5 deaths, 180 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (45 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-1764-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 268 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency department with sceptic shock due to Methicillin-resistant Staphylococcus aureus bacteremia, requiring vasopressor administration. Transesophageal Echocardiography (TEE) confirmed vegetation on the Right Ventricular (RV) lead and Right Atrial (RA) lead. Computerized tomography (CT) scan could not discern if the patient was experiencing pneumonia or sceptic pulmonary emboli. 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: Bacteremia; Drug Resistant Bacterial Infection; Medical device site infection; Pneumonia; Pulmonary Embolism; Sepsis; Septic Shock

  MAUDE report 50691810 ↗
• MalfunctionSep 3, 2026Electromagnetic Interference; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592016 ↗
• MalfunctionJul 2, 2026Device Sensing Problem; Data Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST PACE, RESULTING IN INHIBITION/DELAY OF PACING. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS A MONITORED VENTRICULAR TACHYCARDIA (VT) WITH 1 TO1 SUPRA VENTRICULAR TACHYCARDIA (SVT) ATRIAL EVENTS FALLING INTO THE BLANKING PERIOD. ADDITIONALLY, THE CRT-D DEVICE INTERROGATION REPORTED DISPLAYED AN OBSERVATION WHEN THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS IS PROGRAMMED OFF. 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 25696412 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT HAD EXPERIENCED A STROKE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 25673680 ↗
• InjuryMay 27, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE EPISODE DID NOT MEET DISCRIMINATOR CRITERIA; THEREFORE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED THERAPY PER PROGRAMMING. 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 25306097 ↗
• MalfunctionApr 2, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT WHILE RIDING ON A BUS ON A BUMPY ROAD THE CRTD EXHIBITED INTERMITTENT DETECTION FOR AN ARRYTHMIA. THE PATIENT WAS PUT ON MEDICATION. 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 24768234 ↗
• InjuryMar 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR SHORTNESS OF BREATH. THE TRANSMISSION REPORT WAS REVIEWED AND IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT), SPECIFICALLY ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE RA LEAD AND DEVICE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 24611478 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis

  MAUDE report 24531450 ↗
• MalfunctionFeb 24, 2026Battery Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO ISSUE OR CONCERN WITH THE BATTERY LONGEVITY FROM THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436912 ↗
• MalfunctionFeb 5, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED DUE TO THE PATIENT EXPERIENCING UNSUCCESSFUL HIGH VOLTAGE THERAPY AND THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED WITH THE SUPERIOR VENA CAVA (SVC) COIL TURNED OFF. ON THE SAME DAY, A RV LEAD WARNING TRIGGERED FOR HIGH RV DEFIBRILLATION IMPEDANCE. DURING ADDITIONAL SUCCESSFUL DFT TESTING, THE RV LEAD WAS REPROGRAMMED WITH THE SVC COIL PROGRAMMED ON AND HIGH VOLTAGE IMPEDANCE NORMALIZED. FLUOROSCOPY REVEALED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MIGRATED FROM ITS ORIGINAL POSITION. THE RV LEAD AND CRT-D 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 24274128 ↗
• MalfunctionJan 14, 2026Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069751 ↗
• MalfunctionAug 1, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES.  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A POTENTIAL FOR INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) ON A VENTRICULAR TACHYCARDIA (VT) DUE TO 1:1  ATRIOVENTRICULAR (AV) CORRELATION AND HIGH DEVICE DISCRIMINATOR MATCH SCORES. THE LEAD AND 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 22689281 ↗
• InjuryJun 10, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATORS POTENTIALLY INAPPROPRIATELY WITHHELD VENTRICULAR TACHYCARDIA (VT) DETECTION AND THERAPY. 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: Tachycardia

  MAUDE report 22176152 ↗
• MalfunctionMay 14, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE ATRIAL LEAD WHICH WAS NOTED TO BE ELECTROMAGNETIC INTERFERENCE. 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 22021751 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ENDOCARDITIS INFECTION. BACTEREMIA WAS NOTED AND VEGETATION WAS OBSERVED ON THE VALVES AND LEADS. 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: Bacteremia; Endocarditis; Medical device site infection

  MAUDE report 22006243 ↗
• MalfunctionMay 1, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), AT A PATIENT DEVICE CHECK, IT WAS NOTED THAT THERE WAS AN ESTIMATED FIVE MONTHS REMAINING ON THE BATTERY. A PATIENT FAMILY MEMBER STATED "THE LAST TIME THE PATIENT WAS SEEN IT WAS AT SEVEN MONTHS AND THAT FIVE MONTHS HAD PASSED." ADDITIONALLY, IT WAS INDICATED THE FAMILY MEMBER WAS INSINUATING THAT THE PATIENTS HEALTH ISSUES WERE DUE TO THE BATTERY BEING ¿LOW¿. THE PATIENT FAMILY MEMBER WAS INFORMED THAT THE CRT-D WAS BEING WATCHED AND THAT THE DEVICE WAS INDEED WORKING AS IT SHOULD. 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 21944708 ↗
• InjuryApr 29, 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 FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 21925920 ↗
• InjuryFeb 28, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD A WARNING TRIGGERED FOR HIGH RATE-NON SUSTAINED EPISODES, SENSING INTEGRITY COUNTER FOR SHORT V-V INTERVALS. THE RV LEAD APPEARED TO BE OVERSENSING ON CURRENT ELECTROGRAMS (EGM) AND HIGH RATE-NON SUSTAINED EPISODES. THE OVERSENSING RESULTED IN RATES BELOW PROGRAMMED LOWER RATE OF 60 BEATS PER MINUTE (BPM) WITH NOTED OCCASIONAL V-V INTERVAL OF APPROXIMATELY 40 BPM. IT WAS ALSO REPORTED THAT RV LEAD SENSITIVITY WAS DECREASED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21493172 ↗
• InjuryFeb 25, 2025Device Alarm System; Failure to Interrogate; Device Alarm System; Failure to Interrogate

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL COULD NOT ESTABLISH A CONNECTION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL STARTED WITH A MOBILE PROGRAMMER AND WHEN CONNECTION COULD NOT BE MADE WITH THE DEVICE, THEY ATTEMPTED TWO SEPARATE PROGRAMMERS. THEY THEN TRIED PLACING A MAGNET OVER THE DEVICE AND COULD NOT GET THE DEVICE TO MAKE A TONE. WHEN THE PATIENT ARRIVED FOR A GENERATOR CHANGE, A MOBILE PROGRAMMER WAS USED FROM THE HOSPITAL AND THE DEVICE WAS ABLE TO BE INTERROGATED AND WAS ABLE TO DEMONSTRATE TONES. ONCE THE HEALTHCARE PROFESSIONAL ENDED THE SESSION, A MAGNET WAS PLACED OVER THE DEVICE AND A TONE WAS EMITTED. 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 21462466 ↗
• InjuryJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S REPRESENTATIVE THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT) ON MULTIPLE OCCASIONS AND MANY FALLS, AND INQUIRED WHY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DIDN'T KICK IN. THE REPRESENTATIVE NOTED THAT THE NURSE AT THE HEART CLINIC TOLD THEM IT DOESN'T DO THAT. THE REPRESENTATIVE NOTED THAT THE PATIENT WAS IN THE SHOWER AND WAS KNOCKED OUT COLD ONCE, AND ON ANOTHER OCCASION WAS ON AN ESCALATOR AT THE MALL AND WENT HEADFIRST DOWN THE ESCALATOR. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Loss of consciousness; Tachycardia

  MAUDE report 21143545 ↗
• InjuryDec 27, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED FOR ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WERE NO ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029937 ↗
• InjuryDec 10, 2024Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE TOLD BY THEIR PHYSICIAN THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD BEEN ¿FRIED¿ AFTER IT ¿WENT OFF SEVEN TIMES IN A SHORT PERIOD OF TIME.¿ THE PATIENT FURTHER NOTED THAT THE DEVICE HAD ABOUT THREE YEARS OF BATTERY BUT FOLLOWING THE SEVEN EVENTS IT HAD RUN OUT OF BATTERY AND STOPPED WORKING. THE PATIENT ALSO NOTED THAT THERE WERE ¿VERY UNUSUAL¿ CIRCUMSTANCES AND A HEART INFECTION INVOLVED. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Unspecified Infection

  MAUDE report 20896508 ↗
• MalfunctionDec 9, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSED NOTED IN STORED EPISODES. IT WAS ALSO REPORTED THAT THE ESTIMATED LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS LESS THAN EXPECTED. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AND ALL LEAD AND BATTERY TRENDS WERE APPROPRIATE FOR THE PATIENT'S BASELINE. IT WAS NOTED THAT THE PATIENT WAS NOT TAKING ANY OF THEIR MEDICATION. THE MEDICATION WAS REFILLED AND THEY WERE NOW TAKING AS DIRECTED. THE CRT-D WAS REPROGRAMMED TO ADJUST THE THERAPY ZONES, BUT NOT IN RESPONSE TO THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879589 ↗
• InjuryOct 29, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE 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 20557640 ↗
• MalfunctionOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S WIFE THAT THEY RECEIVED A VOICEMAIL FROM A CLINIC REGARDING A CARDIAC RESYNCHRONIZATION THERAPY DEF IBRILLATOR (CRT-D) ALERT. THE VOICEMAIL INDICATED THAT THERE WAS A POSSIBLE "MISFUNCTION" AND THE PATIENT REPORTED FEELING AS THOUGH "SOMETHING SEPARATED. 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 20443253 ↗