Compia MRI™ CRT-D SureScan™ DTMC1D1 (UDI 00763000060091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000060091), received between Dec 16, 2021 and Jun 10, 2024 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (4 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-1769-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 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 19497983 ↗
• InjuryNov 20, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173703 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MANAGEMENT OF HEART FAILURE, FLUID ACCUMULATION AND LOW BLOOD PRESSURE. THE PATIENT WAS ALSO DIAGNOSED WITH ACUTE KIDNEY INJURY.  THE PATIENT WAS STARTED ON DIURETICS AND BLOOD PRESSURE SUPPORT MEDICATION. DURING THEIR STAY, THE PATIENT HAD A STREPTOCOCCUS AGALACTIAE BACTERIAL INFECTION IN THEIR BLOOD, LIKELY CONTRIBUTING TO THE LOW BLOOD PRESSURE. THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS AND WAS HOSPITALIZED FOR APPROXIMATELY TEN DAYS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Renal Failure

  MAUDE report 17188111 ↗
• MalfunctionJun 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS MOVING AROUND AS THEY GOT OLDER. THE PATIENT STATED THAT THEY COULD FEEL IT WHEN LYING DOWN AND DESCRIBED IT AS ALMOST BEING FLIPPED ON ITS SIDE. 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 17107867 ↗
• InjuryJun 2, 2023Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available; Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available

  IT WAS LATER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON A COMPETITOR LEFT VENTRICULAR (LV) LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052590 ↗
• InjuryApr 12, 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 AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. THE DEVICE WAS EXPLANTED AND REPLACED APPROXIMATELY TWO AND A HALF MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 16724755 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. DURING REMOVAL OF THE LEFT VENTRICULAR (LV) LEAD, THE TIP BROKE OFF IN THE CORONARY SINUS AND WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 16343487 ↗
• InjuryJan 19, 2023Adverse 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 EROSION DUE TO POCKET INFECTION. THE INFECTION REPORTEDLY STEMMED FROM A GENERATOR CHANGE APPROXIMATELY SIX MONTHS PRIOR. THE PATIENT HAD BEEN ON LONG TERM ANTIBIOTICS IN AN EFFORT TO RESOLVE THE ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 16204414 ↗
• InjuryDec 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POTENTIAL PERFORMANCE ISSUE. THE CRT-D WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE REPLACEMENT WAS PROPHYLACTIC DUE TO THE NEED FOR A DEVICE WITH REACTIVE ANTI-TACHYCARDIA PACING THERAPIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051716 ↗
• InjuryDec 15, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS CAUSING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY TO RAPIDLY DRAIN.  THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD WAS CAPPED AND REPLACED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992272 ↗
• MalfunctionMar 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DRAINING AND HAS LESS THAN EXPECTED BATTERY LIFE REMAINING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711929 ↗
• InjuryDec 16, 2021Adverse 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 POCKET INFECTION. EXPLORATION OF THE INCISION SITE WOUND FOUND PUSS. ANTIBIOTIC TREATMENT WAS PERFORMED. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13018519 ↗