Amplia MRI™ CRT-D SureScan™ DTMB1D1 (UDI 00763000059606)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00763000059606), received between Apr 10, 2018 and May 20, 2026 — classified as 1 death, 49 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (16 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-1761-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, A DECREASE IN R-WAVES, AND INCREASE IN PACING IMPEDANCE. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH-RATE NON-SUSTAINED EPISODES AND PACING IMPEDANCE VARIATION. THE LEAD HAD A SUSPECTED RVRING FRACTURE AND TACHYARRHYTHMIA DETECTIONS WERE TURNED OFF. THERE WAS ELECTROMAGNETIC INTERFERENCE/NOISE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERING EPISODE MISCLASSIFICATION AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 25234700 ↗
• InjuryApr 17, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THERE WAS A COMPETITOR LEAD WITH HIGH THRESHOLDS, HIGH IMPEDANCE, AND A PROBABLE FRACTURE. 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 24912955 ↗
• InjuryFeb 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT AN ICD BUT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24433595 ↗
• MalfunctionDec 16, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ATRIAL CHANNEL DURING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE NOISE. THE RIGHT VENTRICULAR (RV) LEAD E XHIBITED A GRADUAL INCREASE IN CAPTURE THRESHOLDS AND PACING IMPEDANCE IN ADDITION TO MULTIPLE ALERTS FOR LOW PACING IMPEDANCE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS TO HIGH LEVELS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS. THE CRT-D AND LEADS 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 23816900 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH SEPSIS, SEPTIC SHOCK AND BACTEREMIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A NEW CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 22153328 ↗
• InjuryApr 1, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED PREMATURE BATTERY DEPLETION. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED INCREASED PACING THRESHOLDS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. THE CRT-D WAS EXPLANTED AND REPLACED. NO ACTIONS WERE TAKEN FOR THE LEADS WHICH 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 21741420 ↗
• InjuryMar 28, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 21723824 ↗
• InjuryMar 28, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), COMPETITOR LEAD HIGH LV THRESHOLD AND OUTPUT LEAD TO LESS THAN WARRANTED LONGEVITY. 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 21721264 ↗
• InjuryJan 8, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD UNDERSENSING NOTED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY CLASSIFIED A VENTRICULAR TACHYCARDIA (VT) EVENT AS SUPRA VENTRICULAR TACHYCARDIA (SVT) RESULTING IN WITHHOLDING OF THERAPY. THE RA LEAD, RV LEAD AND CRT-D REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21106688 ↗
• InjuryDec 13, 2024Adverse 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 EVIDENCE OF BACTEREMIA. THE PATIENT REPORTED EXPERIENCING DISCOMFORT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Discomfort; Unspecified Infection

  MAUDE report 20929335 ↗
• InjuryDec 3, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE. IT WAS NOTED THAT THE EMERGENCY MEDICAL SERVICES REPORTED THE PATIENT HEART RATE IN THE TWENTIES BEATS PER MINUTE, WHICH IS LOWER THAN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER PACING RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 20835846 ↗
• MalfunctionNov 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING THRESHOLDS AND LOSS OF CAPTURE. IT WAS ALSO REPORTED, A RA LEAD IM PEDANCE WARNING TRIGGERED FOR HIGH UNDEFINED BIPOLAR IMPEDANCE, HOWEVER IMPEDANCES WERE NOTED TO BE STABLE. THE RA LEAD REMAINS IN USE. ADDITIONALLY, CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HIGHER BATTERY DRAIN NOTED, WITH PRE-ARRHYTHMIA ELECTROGRAMS (EGM) IS SET TO ON CONTINUOUS. 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 20774721 ↗
• MalfunctionNov 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SETSCREW WAS UNABLE TO BE ENGAGED OR TURNED. THE CRT-D WAS REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686135 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PLANNED LEAD PROCEDURE, UPON INCISION OF SITE, PUSS WAS FOUND. THE PHYSICIAN DECIDED TO SWAB THE POCKET, AND CLOSE BACK UP. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED DISCOMFORT. SUBSEQUENTLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Purulent Discharge; Unspecified Infection

  MAUDE report 20558627 ↗
• InjuryAug 21, 2024High impedance; Mechanical Problem; Impedance Problem; High impedance; Mechanical Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCES OF THE RV COIL ALONG WITH IMPEDANCE SPIKES. IT WAS FURTHER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE RV LEAD EXHIBITED HIGH OOR DEFIBRILLATION IMPEDANCES. A CHEST X-RAY CONFIRMED THAT THE RV COIL PIN WAS NOT FULLY SEATED IN THE HEADER. DURING A REVISION PROCEDURE THE HEADER WAS INSPECTED AND THE PIN APPEARED TO BE FULLY SEATED, AND A TUG TEST WAS COMPLETED DURING WHICH NONE OF THE LEADS WERE NOTED TO BE LOOSE. THE RV LEAD WAS DISCONNECTED AND TESTED WITH AN ANALYZER WHICH SHOWED NO EVIDENCE OF NOISE AND IMPEDANCE AND THRESHOLD MEASUREMENTS WERE STABLE. THE RV LEAD WAS RECONNECTED AND THE SUBSEQUENT IMPEDANCE VALUES WERE NOTED TO BE LOWER AND STABLE. THE POCKET WAS CLOSED. TWO DAYS LATER AN ALERT WAS TRIGGERED FOR OOR HIGH SVC IMPEDANCE, VARYING SVC IMPEDANCE WAS ALSO NOTED, AND NON PHYSIOLOGIC NOISE WAS OBSERVED ON ELECTROGRAMS (EGM). FRACTURE OF THE SVC COIL WAS SUSPECTED. THE SVC COIL WAS PROGRAMMED OFF AND THE CLINICIAN WILL CONTINUE TO MONITOR THE RV COIL. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO PATIENT COMPLICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013361 ↗
• MalfunctionMay 17, 2024Electrical /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 19345544 ↗
• DeathMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS ADMITTED TO THE HOSPITAL DUE TO SEPTIC SHOCK. THE PATIENT PASSED AWAY DUE TO NON-CARDIAC ISSUES.

  Patient problems: Septic Shock

  MAUDE report 18940035 ↗
• InjuryFeb 20, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE RARE UNDER SENSING NOTED AT TERMINATION OF MONITORED VENTRICULAR TACHYCARDIA (VT) SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES.  THE RA LEAD REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.  THE PATIENT WAS IN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) AT THE TIME OF THE HIGH VOLTAGE 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: Shock from Patient Lead(s)

  MAUDE report 18740528 ↗
• MalfunctionFeb 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LONGEVITY ESTIMATOR DISPLAYED A GRAY BAR INDICATING BATTERY VOLTAGE BELOW INDICATION FOR IMPLANT. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729818 ↗
• MalfunctionFeb 15, 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 18716631 ↗
• 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 18580796 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND WAS HOLDING THEIR CHEST. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED STROKES AND MAY HAVE BEEN HOLDING THEIR CHEST FOR THAT REASON. 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: Chest Pain; Stroke/CVA

  MAUDE report 18366030 ↗
• MalfunctionDec 11, 2023Electrical /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 DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303737 ↗
• MalfunctionDec 5, 2023Electrical /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 DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270982 ↗
• InjuryNov 21, 2023Failure 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) MAY HAVE INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18185946 ↗