Amplia MRI™ CRT-D SureScan™ DTMB1D4 (UDI 00763000059675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00763000059675), received between Feb 8, 2018 and Aug 6, 2026 — classified as 4 deaths, 39 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (21 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-1762-2023 · 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.

• MalfunctionAug 6, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161416 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25668763 ↗
• InjuryFeb 6, 2026Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERAPY WAS POTENTIALLY INAPPROPRIATELY WITHHELD BY PR LOGIC FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS ALSO NOTED THAT ON ANOTHER INSTANCE THE CRT-D MAY HAVE DELAYED THERAPY FOR A VT EPISODE DUE TO THE ATRIAL FIBRILLATION (AF)/ATRIAL FLUTTER DISCRIMINATOR. 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 24279289 ↗
• InjuryNov 21, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE FOR FIFTEEN TO TWENTY SECONDS. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO BE PROGRAMMED SUB-THRESHOLD. ADDITIONALLY, IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOSS OF BI-VENTRICULAR SUPPORT DURING ATRIAL CAPTURE MANAGEMENT(ACM) OPERATION WHEN THE DEVICE AUTOMATICALLY MONITORS ATRIAL PACING THRESHOLDS AT PERIODIC INTERVALS. IT WAS ALSO NOTED THAT THE CRT-D DEVICE HAD NOT COMPLETED ACM AT THE TIME OF THE THE REMOTE TRANSMISSION SO WOULD HAVE TRIED AT 30 MIN INTERVALS. IN ADDITION, THE PHYSICIAN ALSO WAS QUESTIONING THE LEFT BUNDLE BRANCH LEAD. THE RV LEAD, CRT-D AND LEFT BUNDLE BRANCH LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 23622366 ↗
• MalfunctionOct 27, 2025Under-Sensing; Data Problem; Under-Sensing; Data Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF THE THRESHOLD VALUE. IT WAS ALSO REPORTED THAT THE CRT-D APPEARED TO BE OCCASIONALLY UNDERSENSING AND/OR BLANKING ON ATRIAL LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) EVENT(S). THE CRT-D AND THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED IMPEDANCE WARNING LVTIP TO RVCOIL FOR HIGH UNDEFINED IMPEDANCE AND POSSIBLE CAPTURE ISSUE NOTED. THE LV 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 23396856 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPTICEMIA/SEPTIC SHOCK. THE SOURCE OF THE INFECTION IS UNKNOWN. THE PHYSICIAN SUSPECTED THE LEADS WERE INFECTED ALTHOUGH THE POCKET SHOWED NO SIGNS OF INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 23016013 ↗
• InjuryJun 25, 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 ANTIARRHYTHMIC PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE A DUAL TACHYCARDIA. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR HIGH THRESHOLDS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 22327873 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT DURING THE POCKET REVISION FOR THE POCKET HEMATOMA, THE CRT-P WAS REMOVED WITH LEADS CONNECTED AND BLEEDERS WERE CAUTERIZED, THE POCKET WAS IRRIGATED WITH ANTIBIOTIC SOLUTION, AND THE CRT-P DEVICE RETURNED TO POCKET AND INCISION SUTURED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 21861680 ↗
• InjuryJan 24, 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 DUE TO INFECTION, ORGANISM UNKNOWN. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21232388 ↗
• MalfunctionNov 26, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT) AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. 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 20787157 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLANT WITH NO REPLACEMENT OCCURRED DUE TO A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION INVOLVING MULTIPLE IMPLANTABLE DEVICES, INCLUDING A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (AMPLIA MRI US DF4) AND ASSOCIATED LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 20748423 ↗
• MalfunctionNov 12, 2024Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOTED ON A NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE. IT WAS AN EPISODE OF NOISE THAT HAD NOT BEEN SEEN IN THE PAST. A FEW SHORT VENTRICULAR INTERVALS WERE ALSO NOTED. 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 20663866 ↗
• InjuryOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEM INFECTION. THE ORIGINAL LOCATION OF THE INFECTION WAS NOTED TO BE BACTEREMIA. IT WAS NOTED THAT THE PATIENT HAD DISCOMFORT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. THERIGHT VENTRICULAR (RV) LEAD WAS INACTIVATED AND LATER REMOVED BY LASER LEAD EXTRACTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 20435437 ↗
• MalfunctionAug 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN EXTRA PACER SPIKE WAS NOTED BETWEEN BEATS OBSERVED ON EXTERNAL TELEMETRY. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT OVERSENSING CAUSING PACING INHIBITION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907689 ↗
• InjuryJun 21, 2024Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO A POTENTIAL PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583399 ↗
• DeathMay 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT MAY HAVE EXPERIENCED BEING IN VENTRICULAR TACHYCARDIA (VT) FOR APPROXIMATELY TWELVE HOURS. ADDITIONAL INFORMATION WAS PROVIDED THAT INDICATED THE PATIENT ENTERED HOSPICE CARE AND SUBSEQUENTLY PASSED AWAY. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Tachycardia

  MAUDE report 19255273 ↗
• InjuryApr 19, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING AND DEFIBRILLATION THERAPY FOR AN EPISODE O F SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE WAS IN PROGRESS DURING THERAPY. 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 19144124 ↗
• InjuryApr 18, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND SYNCOPE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON THE CURRENT AND STORED ELECTROGRAMS (EGM). IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING AND NOT PACING. THE RA LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting; Tachycardia

  MAUDE report 19135474 ↗
• InjuryApr 16, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS SUDDENLY INCREASED AND WERE HIGH. THIS LED TO ACUTE DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY. THE RV LEAD AND CRT-D WERE 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 19117544 ↗
• InjuryApr 2, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FOR EPISODES WITH FAST ATRIAL AND VENTRICULAR RATES THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19023420 ↗
• InjuryMar 21, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS LATER REPORTED BY THE PATIENT'S FOLLOWING PHYSICIAN THAT THE THERAPIES WERE APPROPRIATE. THE PATIENT WAS STARTED ON ANTIARRHYTHMIC AND OTHER MEDICATION.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18952640 ↗
• InjuryMar 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A MAGNET WAS PLACED OVER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO THE PATIENT ENTERING HOSPICE CARE; HOWEVER, THE DEVICE SHOCKED THE PATIENT TWICE AND WOULD NOT STOP SHOCKING THE PATIENT. 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 18889027 ↗
• MalfunctionMar 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LONGEVITY 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 18887620 ↗
• MalfunctionMar 2, 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. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823432 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, IT WAS REPORTED THAT THE CAUSE OF THE ALLERGIC REACTION WAS UNKNOWN. THE PATIENT WAS PRESCRIBED HYDROCORTISONE AND REFERRED TO SEE AN ALLERGY/IMMUNOLOGY SPECIALISTS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18705578 ↗