Compia MRI™ CRT-D SureScan™ DTMC1D1 (UDI 00643169705807)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169705807), received between Jun 8, 2017 and Jul 18, 2024 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

2 FDA recall records 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. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0583-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH-VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS A RESULT OF ELECTROMAGNETIC INTERFERENCE FROM CAUTERY DURING A SURGICAL PROCEDURE. IT WAS ALSO NOTED THAT DURING THIS PROCEDURE, THERE WAS AN ALERT FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. 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 19773868 ↗
• InjuryNov 11, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MIGRATED LATERALLY ALMOST INTO THE PATIENT'S ARMPIT. 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; No Consequences Or Impact To Patient

  MAUDE report 10822292 ↗
• InjuryOct 28, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS LATER CONFIRMED THAT THE SHOCKS WERE APPROPRIATE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10748994 ↗
• InjuryJan 16, 2019Adverse 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 REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8252912 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A DEVICE IN THE MEDICAL EQUIPMENT COMPANY REPRESENTATIVE'S STOCK DISPLAYED A GRAY BATTERY STATUS BAR. THE DEVICE WAS STORED INDOOR FOR OVER THREE DAYS, BUT THE ISSUE PERSISTED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461748 ↗
• MalfunctionApr 25, 2018Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO THE USE, DEVICE BATTERY LONGEVITY SHOWED GREY BAR. THE DEVICE WAS OPENED AND NOT USED. NO PATIENT WAS INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7460732 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE BELOW INDICATION FOR IMPLANT ON MULTIPLE OCCASIONS. THE DEVICE WAS NEVER ATTEMPTED TO BE IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7460007 ↗
• MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED AND THE BATTERY LONGEVITY STATUS BAR WAS GRAY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416087 ↗
• MalfunctionApr 2, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS INTERROGATED AND THE REMAINING LONGEVITY ESTIMATE GRAPHIC INDICATOR BAR WAS GRAY. THE DEVICE WAS NOT USED. THERE WAS NO APPARENT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7389678 ↗
• MalfunctionOct 6, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) SETSCREW WOULD NOT WORK DURING IMPLANT. THE PHYSICIAN MADE MULTIPLE ATTEMPTS AND ALSO TRIED AN ADDITIONAL WRENCH BUT THE SCREW STILL DID NOT WORK. A DIFFERENT CRT-D WAS SUBSEQUENTLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6923886 ↗
• MalfunctionJun 8, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SETSCREW WAS NOT THREADED STRAIGHT ONCE IT WAS BACKED OUT AND THAT THE SCREW COULD NOT BE ACCESSED WITH A DEVICE WRENCH. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6628018 ↗