Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ (UDI 00643169720749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00643169720749), received between Jun 12, 2018 and Aug 6, 2026 — classified as 4 deaths, 46 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (12 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-1770-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50162064 ↗
• InjuryNov 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED A SHOCK AFTER A MAGNET WAS PLACED OVER THE DEVICE. 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 23567301 ↗
• InjuryApr 24, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT TREAT A VENTRICULAR TACHYCARDIA (VT) EPISODE DUE TO DEVICE DISCRIMINATORS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THAT THE LEAD HAD BEEN PREVIOUSLY BEEN REPROGRAMMED DUE TO FAR FIELD R-WAVE (FFRW) OVERSENSING. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21898252 ↗
• InjuryMar 19, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AN EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND WITHHELD FOR SINUS TACHYCARDIA WHEN THE RHYTHM WAS VENTRICULAR TACHYCARDIA (VT) WITH RETROGRADE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21643100 ↗
• DeathFeb 13, 2025Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem; Data Problem; Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem; Data Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF A THRESHOLD VALUE WHEN THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS IS PROGRAMMED OFF. IT WAS FURTHER REPORTED THAT WHILE SLEEP IN BED IN THE EARLY MORNING, THE PATIENT WENT INTO A POLYMORPHIC VENTRICULAR TACHYCARDIA (VT) AS STATED BY THE PHYSICIAN. IT WAS NOTED THAT THE PATIENT DEVELOPED AN UNSTABLE VENTRICULAR TACHYCARDIA (VT) THAT DETERIORATED INTO VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE THAT HELPS PREVENT THE INAPPROPRIATE DETECTION OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS A VENTRICULAR TACHYARRHYTHMIA BY EVALUATING THE STABILITY OF VENTRICULAR INTERVALS, INITIALLY DELAYED THERAPY EVEN AFTER SEVERAL ROUNDS OF ANTI-TACHYCARDIA PACING (ATP). THE THERAPY NEVER LED TO A DEFINITIVE SHOCK AND THE PATIENT ULTIMATELY PASSED AWAY AS A RESULT OF CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 21376675 ↗
• InjuryOct 30, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN OFFICE NOTED THAT ATRIAL FIBRILLATION (AF) ABLATION WAS PERFORMED AND REPROGRAMMED WAS DONE AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20569402 ↗
• InjuryMar 14, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DELETION DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS SET AT IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED, AND A NEW LV LEAD VECTOR WAS BEING UTILIZED TO AID IN BATTERY LONGEVITY. 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 18908777 ↗
• InjuryMar 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION AND EXPERIENCED REDNESS AND SWELLING. THE ORGANISM WAS IDENTIFIED AS ENTEROCOCCUS FAECALIS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Erythema; Swelling/ Edema

  MAUDE report 18823461 ↗
• MalfunctionJan 26, 2024Pacing Problem; Capturing Problem; Pacing Problem; Capturing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE DEVICE HAD A "RHYTHM ISSUE", THE PATIENT'S HEART RATE WAS INITIALLY AT 90 BEATS PER MINUTE (BPM), THEN HAD A PAUSE, FOLLOWED BY THREE BEATS AT 90 BPM, ANOTHER PAUSE, AND THEN CONTINUED.  IT WAS SUSPECTED THAT THE ISSUE MIGHT BE RELATED TO THE CRT-D FEATURE THAT MONITORS AND AUTO ADJUST LEFT VENTRICULAR THRESHOLD CAPTURE, BUT COULD NOT BE CONFIRMED.  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 18587785 ↗
• DeathDec 12, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIALLY INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL EPISODES THAT DID NOT APPEAR TO IMPACT DEVICE FUNCTION. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Shock from Patient Lead(s)

  MAUDE report 18312272 ↗
• InjuryNov 13, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNRESPONSIVE WITH LOW BLOOD PRESSURE. NO PACING WAS OBSERVED ON THE  ELECTROCARDIOGRAM. TEMPORARY PACING WAS ADMINISTERED AFTER WHICH THE PATIENT WAS RESPONSIVE. 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: Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 18119724 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE SEPSIS THAT RESULTED IN THE LEFT SIDED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM BEING EXPLANTED. IT WAS NOTED THE SEPSIS WAS UNRELATED TO THE DEVICE AND LEADS, HOWEVER, THE SOURCE IS UNKNOWN. A NEW CRT-D SYSTEM WAS IMPLANTED ON THE RIGHT SIDE SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 17715606 ↗
• InjuryJun 30, 2023Mechanical Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A CONFIRMED FRACTURE. IN ADDITION, DURING THE RV LEAD REPLACEMENT P ROCEDURE, THERE WAS EXTRACTION DIFFICULTY WITH AN OLD ABANDONED PACING RV LEAD. IT WAS NOTED THAT THE PACING RV LEAD WAS SEVERELY SCARRED AND ADHERENT TO THE OTHER LEADS IN THE PATIENT¿S INNOMINATE VEIN. THE PACING RV LEAD WAS CAPPED AND PARTIALLY EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238871 ↗
• InjuryJun 19, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS REPORTED THAT DURING THE PATIENT¿S BREAST PROCEDURE, THE DEVICE WAS TONING RANDOMLY, AND NON-WIRELESS TELEMETRY SESSION AUTOMATICALLY SUSPEND DETECTIONS.  IT WAS ALSO REPORTED THAT DURING CAUTERY, THE PATIENT RECEIVED A SHOCK. A REVIEW OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DATA REVEALED MULTIPLE MAGNET TRIPS OCCURRED DURING THE PROCEDURE WHICH ARE SUGGESTIVE THAT THE MAGNET WAS MOVING ON AND OFF DURING THE PROCEDURE SINCE TYPICALLY IT IS EXPECTED ONLY 1 MAGNET TRIP AT THE BEGINNING OF THE PROCEDURE.  IT WAS ALSO NOTED THAT AS A RESULT OF THE MULTIPLE MAGNET APPLICATIONS, A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO, TWO OR MORE CRITERIA HAD BEEN MET FOR HIGH RATE NON-SUSTAINED EPISODES, SHORT V-V INTERVALS AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCE.  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 17159737 ↗
• InjuryJun 6, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCKS. IT WAS NOTED THAT THE DEVICE WAS INITIALLY WITHHOLDING THERAPY APPROPRIATELY, BUT THE DISCRIMINATORS STOPPED ABRUPTLY DUE TO THE WAVELET MATCH DROPPING TOO LOW. IT WAS NOTED THAT THE TEMPLATE HAD NOT BEEN UPDATED FOR SEVERAL YEARS. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE CRT-D AND THE 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 17071426 ↗
• InjuryJun 2, 2023Adverse 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17050929 ↗
• DeathApr 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN THE EMERGENCY ROOM BEFORE THE DEVICE COULD BE INTERROGATED. THE DEVICE RELATION TO THE PATIENT'S DEATH IS UNKNOWN. THE CAUSE OF DEATH WAS REQUESTED AND WAS NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16802861 ↗
• InjuryApr 19, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. A REVIEW OF THE REMOTE TRANSMISSION REVEALED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT INITIALLY THERAPIES WERE WITHHELD BY THE ATRIAL FIBRILLATION (AF)/ATRIAL FLUTTER DISCRIMINATOR. THE CRT-D REMAINS IN USE. IT WAS ALSO REPORTED THAT THERE APPEARED TO BE RIGHT ATRIAL (RA) LEAD UNDERSENSING. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Shock from Patient Lead(s)

  MAUDE report 16773045 ↗
• InjuryMar 14, 2023Premature 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 16540406 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO SEPSIS. THE CRT-D SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 16436604 ↗
• InjuryDec 21, 2022Premature 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 16022780 ↗
• MalfunctionOct 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS TOLD BY THEIR NEW CARDIOLOGIST THAT THE NEW SETTINGS ON THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WERE "PUTTING A STRAIN ON THE BATTERY AND CAUSING IT NOT TO LAST AS LONG AS THEY ORIGINALLY ESTIMATED." 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 15567991 ↗
• InjuryAug 4, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. REPROGRAMMING WAS PREFORMED AND 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 15163018 ↗
• InjuryMay 23, 2022Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14476345 ↗
• InjuryFeb 11, 2022Premature 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 13518409 ↗