Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1 (UDI 00643169929630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169929630), received between Dec 10, 2018 and Feb 22, 2024 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO OR MORE INAPPROPRIATE HIGH VOLTAGE THERAPIES BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THE DETECTION OF AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE THAT WAS 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 18760148 ↗
• InjuryAug 24, 2021Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FIVE SHOCKS, BUT THE ENTIRE EPISODE WAS UNABLE TO BE VIEWED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THAT THE ELECTROGRAMS (EGM) RECODING ENDED, BECAUSE THE THERAPY SEQUENCE WAS GREATER THAN THE STORAGE LIMIT. 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; Shock from Patient Lead(s)

  MAUDE report 12362437 ↗
• InjuryApr 19, 2021Failure 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) AND TREATMENT WAS WITHHELD FOR TWO AND A HALF HOURS. THIS WAS DUE TO THE PROGRAMMING OF THE FEATURE THAT DETECTS IF THE WAVEFORM SUFFICIENTLY MATCHES THE TEMPLATE. 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 11685079 ↗
• InjuryMar 5, 2021Mechanical Problem; Mechanical Problem

  THERE WAS NO ACTUAL CONNECTION ISSUE WITH THE CRT-D HEADER AND THE NEW RV LEAD. THE CRT-D WAS SIMPLY REPLACED TO ACCOMMODATE THE CONNECTOR OF THE NEW RV LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421557 ↗
• MalfunctionNov 23, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PARTIAL ELECTRICAL RESET DURING PROGRAMMER INTERROGATION. 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 10885215 ↗
• InjuryOct 1, 2020Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT WHILE THE PATIENT WAS IN A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO ELECTROMAGNETIC INTERFERENCE. THE ICD 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 10615911 ↗
• InjurySep 4, 2020Adverse 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 10497498 ↗
• InjuryMar 16, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT THERE WAS A POWER ON RESET (POR) ON THE DEVICE. THE DEVICE WAS INTERROGATED AND THE POR WAS CLEARED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9835839 ↗
• InjuryFeb 26, 2020Adverse 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 REMOVED DUE TO VEGETATION NOTED ON THE ATRIAL LEAD BODY IN THE PATIENT'S RIGHT ATRIUM. PRE-EXTRACTION BLOOD CULTURES WERE NEGATIVE FOR BACTERIA GROWTH. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9758514 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8638814 ↗
• InjuryApr 22, 2019Adverse 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 REMOVED DUE TO INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8536367 ↗
• MalfunctionMar 6, 2019Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AS THE BATTERY VOLTAGE DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8394489 ↗
• MalfunctionFeb 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE CRT-D, RA LEAD, AND LV LEAD WERE EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333630 ↗
• MalfunctionJan 29, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE WAS CONFIRMING THE STATUS OF VARIOUS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES, THE DEVICE WAS INTERROGATED, AND THE BATTERY LONGEVITY STATUS BAR WAS GRAY. IT WAS NOTED THAT THE DEVICE HAD BEEN STORED IN COLD WEATHER PERIODICALLY. IT WAS FURTHER REPORTED THAT DESPITE BEING PLACED IN A WARM ENVIRONMENT FOR SEVERAL DAYS, THE DEVICE WOULD NOT FLIP BACK TO A NON-GRAY BAR STATUS. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8287285 ↗
• MalfunctionDec 11, 2018High impedance; High impedance

  IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, WHEN THE CHRONIC COMPETITOR RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE DEVICE, UNDEFINED HIGH IMPEDANCE WAS NOTED ON THE RV PACE/SENSE PORT. THE LEAD WAS CHECKED VIA THE ANALYZER AS WELL AS THE OLD DEVICE, AND THE IMPEDANCE WAS FINE. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151587 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED AND A TEMPORARY LEAD WAS IMPLANTED. A NEW DEVICE AND LEADS WILL BE PLACED AT A LATER DATE WHEN THE INFECTION CLEARS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8146957 ↗