Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ (UDI 00643169565272)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00643169565272), received between Dec 9, 2016 and Jun 3, 2024 — classified as 2 deaths, 35 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (14 reports).

3 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 ↗

3. Apr 12, 2017Class IITerminated

   An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

   Z-2117-2017 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE BATTERY DEPLETION WAS BELIEVED TO BE NORMAL AND THAT REPLACEMENT WAS PROPHYLACTIC DUE TO THE DEVICE REACHING ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454208 ↗
• InjuryNov 17, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS SUSPECTED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR ATRIAL FIB RILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR FIBRILLATION (VF). ADDITIONALLY, IT WAS NOTED THAT THERE WAS A HIGH/UNDEFINED BIPOLAR IMPEDANCE WARNING ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D AND RA 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 18163081 ↗
• InjuryJul 11, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17300397 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND GOT A HEMATOMA AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET SITE. APPROXIMATELY A MONTH LATER, THE PATIENT DEVELOPED A POCKET INFECTION. THE CRT-D SYSTEM WAS EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 15498816 ↗
• InjuryApr 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LONGEVITY DROPPED QUICKLY AND DID NOT LAST AS LONG AS THEY EXPECTED. 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

  MAUDE report 14022009 ↗
• MalfunctionFeb 10, 2022Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POWER ON RESET (POR). 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 13505540 ↗
• InjuryJan 4, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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

  MAUDE report 13151266 ↗
• MalfunctionNov 18, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12835920 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTED VALVE WITH ENDOCARDITIS AND VEGETATION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 12166503 ↗
• InjuryJul 9, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED RAPID BATTERY DEPLETION AND REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) UNEXPECTEDLY. 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

  MAUDE report 12148042 ↗
• InjuryApr 9, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. IT WAS ALSO NOTED THAT THE LV LEAD HAD PULLED BACK. THE CRT-D AND LV LEAD 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 11641165 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. THE DEVICE SYSTEM WAS REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 11308133 ↗
• InjuryDec 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 11087833 ↗
• MalfunctionDec 15, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED TACHYCARDIA EPISODES. THE PATIENT WAS INDICATED TO HAVE BEEN IN SURGERY AT THE TIME OF THE EPISODES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 11012026 ↗
• InjuryDec 3, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE BATTERY DEPLETED QUICKER THAN EXPECTED, WITH AN ALERT FOR THE DEVICE REACHING RECOMMENDED REPLACEMENT TIME (RRT). 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

  MAUDE report 10938051 ↗
• InjuryNov 17, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND THAT ATTEMPTS TO REPOSITION AND THEN EXPLANT THE LEAD WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED. 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 10854142 ↗
• InjuryNov 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC AND NERVE STIMULATION. IT WAS ADDITIONALLY NOTED THAT THE CARDIAC RESYNCH RONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809812 ↗
• MalfunctionSep 29, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED AN ELECTRICAL RESET DURING INTERROGATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599435 ↗
• InjurySep 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION DUE TO HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580155 ↗
• InjuryJun 19, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED ELECTRICAL RESET. THE RESET WAS CLEARED AND PROGRAMMED BACK TO ORIGINAL VALUES. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174762 ↗
• InjuryMar 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION. THE CRT-D WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9852702 ↗
• InjuryJan 27, 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 AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9632204 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AROUND THE DEVICE. CULTURES WERE TAKEN AND THE ORGANISM IS UNKNOWN. THE DEVICE AND LEADS WERE EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9595896 ↗
• InjuryNov 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED HIGH THRESHOLDS AND LOSS OF CAPTURE. THE CRT-D WAS EXPLANTED AND REPLACED, AND THE LV LEAD 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 9311313 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8825032 ↗