Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ (UDI 00763000059996)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00763000059996), received between Dec 15, 2020 and Jul 13, 2026 — classified as 41 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (9 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION AND POSSIBLE INFECTION. IT WAS ALSO REPORTED THAT DURING RIGHT ATRIAL (RA) LEAD EXPLANT, A STYLET WAS INTRODUCED INTO THE RA LEAD LUMEN, THE HELIX WAS RETRACTED, AND THE LEAD WAS WITHDRAWN FROM THE RIGHT ATRIUM. HOWEVER, THE LEAD COULD NOT BE REMOVED PAST THE LEFT SUBCLAVIAN VEIN DESPITE MULTIPLE ATTEMPTS. FLUOROSCOPY SHOWED THE RA LEAD HAD BEEN DAMAGED DUE TO MANUAL STRESS DURING REMOVAL ATTEMPTS. AFTER THE STYLET WAS WITHDRAWN, IT COULD NOT BE RE-ADVANCED FULLY BECAUSE OF THE DAMAGED SEGMENT REMAINING IN THE SUBCLAVIAN VEIN. MULTIPLE SNARE ATTEMPTS VIA THE RIGHT FEMORAL VEIN WERE UNSUCCESSFUL, SO THE EXPOSED PORTION OF THE RA LEAD WAS CUT AND REMOVED, WHILE THE DAMAGED REMAINING SEGMENT WAS LEFT EMBEDDED IN FIBROUS TISSUE WITHIN THE LEFT SUBCLAVIAN VEIN AND REMAINS IN THE PATIENT. 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: Erosion; Unspecified Infection

  MAUDE report 25793593 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO VEGETATION IDENTIFIED ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25155822 ↗
• InjuryApr 1, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS MALPOSITIONED AND NONFUNCTIONAL. IN ADDITION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. DURING THE REVISION PROCEDURE; IT WAS DETERMINED TO REPLACE THE LV LEAD WITH AN EPICARDIAL LEAD. DURING ATTEMPTED EXTRACTION; SIGNIFICANT SCAR TISSUE WAS NOTED ON THE LV LEAD. THE LV LEAD COULD NOT BE EXTRACTED. THE LV LEAD WAS CAPPED AND REPLACED. IN ADDITION, THE CRT-D HEADER WAS INCOMPATIBLE WITH THE EPICARDIAL LEAD. 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 24755840 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24500425 ↗
• InjuryFeb 12, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED INAPPROPRIATE THERAPY. IT WAS NOTED THAT THE HOSPITAL COULD NOT DETERMINE WHY THE PATIENT HAD BEEN SHOCKED. 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 24328766 ↗
• InjuryJan 7, 2026Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL FLUTTER (AFL) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). FOLLOW UP CONFIRMED THE PATIENT WAS IN DUAL TACHYCARDIA AND THE THERAPIES WERE APPROPRIATE. 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); Tachycardia

  MAUDE report 23993752 ↗
• InjuryNov 20, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY CLASSIFIED A VENTRICULAR FIBRILLATION (VF) EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT) VIA THE DEVICE FEATURE THAT USES PATTERN AND RATE ANALYSIS TO DISCRIMINATE BETWEEN SVT AND TRUE VENTRICULAR TACHYARRHYTHMIAS. THERAPY WAS INITIALLY WITHHELD BUT EVENTUALLY WAS DELIVERED AFTER A MINUTE DELAY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23610288 ↗
• InjuryNov 14, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE 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 23555029 ↗
• MalfunctionOct 24, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AS OBSERVED IN STORED ELECTROGRAMS (EGM). IT WAS FURTHER REPORTED THAT THE PATIENT'S HEART RATE WAS BETWEEN 20-60 BEATS PER MINUTE, AND THE PROGRAMMED LOWER RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS 60 BEATS PER MINUTE. THE RV LEAD AND DEVICE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23383348 ↗
• InjurySep 12, 2025Premature 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 23045707 ↗
• MalfunctionSep 11, 2025Electrical /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 23026629 ↗
• MalfunctionAug 26, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896095 ↗
• InjuryJul 5, 2025Adverse 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 DEVICE SITE INFECTION AND EROSION. THE PATIENT EXPERIENCED WOUND DEHISCENCE, DRAINAGE FROM THE INCISION AND POCKET PAIN. THE SYSTEM WAS REPLACED THREE DAYS AFTER EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Medical device site infection; Pain; Pocket Erosion; Wound Dehiscence

  MAUDE report 22407338 ↗
• MalfunctionJun 26, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY TREATED WITH ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR ATRIAL TACHYCARDIA (AT) MIS-DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 22340488 ↗
• InjuryMar 20, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE FOR AN AORTIC ROOT THROMBECTOMY. IT WAS NOTED THAT DURING THE PROCEDURE THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT) BUT A SIGNIFICANT AMOUNT OF OVERSENSING WAS SEEN AND A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR THE HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). ADDITIONALLY HIGH VOLTAGE THERAPY WAS PROVIDED FOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED VENTRICULAR FIBRILLATION (VF) EPISODES PRIOR TO MAGNET PLACEMENT. THE PATIENT WAS HOSPITALIZED AND THE DEVICE REMAINS IN USE. IT WAS ALSO REPORTED THAT THERE WAS A HIGH RA LEAD THRESHOLD NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Thrombosis/Thrombus

  MAUDE report 21655064 ↗
• InjuryFeb 6, 2025Premature 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 AND THE NEW DEVICE WAS PROGRAMMED WITH NEW PARAMETERS TO MAXIMIZE THE BATTERY LONGEVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327162 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN INFECT ION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21027572 ↗
• MalfunctionOct 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED VARIABLE THRESHOLDS THAT POSSIBLY CONTRIBUTED TO A LOWER-THAN-EXPECTED ESTIMATED BATTERY LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ADDITIONALLY, OVERSENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393521 ↗
• MalfunctionOct 2, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND EMERGENCY MEDICAL SERVICES REPORTED BRADYCARDIA TO THIRTY BEATS PER MINUTE, WHICH WAS BELOW THE PROGRAMMED LOWER RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dyspnea

  MAUDE report 20356540 ↗
• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA 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: Bacteremia

  MAUDE report 20329566 ↗
• InjuryAug 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20058839 ↗
• MalfunctionMay 7, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WIDE COMPLEX TACHYCARDIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AN SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 19263658 ↗
• InjuryApr 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AFTER PROGRAMMING CHANGES WERE MADE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ADDITIONALLY, IT WAS NOTED THAT THE PATIENT EXPERIENCED POSSIBLE PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. FOLLOW UP WAS CONDUCTED AND INDICATED THAT NO INTERVENTION WAS PERFORMED. THE CRT-D AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 19168904 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSITIVE BLOOD CULTURES FOR INFECTION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED EVIDENCE OF VEGETATION ON ONE OF THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT WAS DISCHARGED HOME WITH AN EXTERNAL, WEARABLE DEFIBRILLATOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18885139 ↗
• MalfunctionFeb 12, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THEY HAD A SLEEP STUDY DONE, AND HAD HEART RATES DROPPING BELOW THEIR PROGRAMMED SETTINGS. 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: Bradycardia

  MAUDE report 18691146 ↗