Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ (UDI 00643169929715)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169929715), received between Jun 27, 2018 and Aug 22, 2024 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS FURTHER REPORTED BY HEALTHCARE PROFESSIONAL THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER GETTING MULTIPLE SHOCKS BY THE CRT-D. THE PATIENT WAS ALSO SEPTIC, DUE TO SOME SORT OF BOWEL OBSTRUCTION. THE PATIENT WAS NOTIFIED THAT THE DEVICE WAS NON-FUNCTIONAL AND COULD NOT DELIVER THERAPIES. AFTER SPEAKING WITH THE FAMILY, PATIENT WAS DISCHARGED TO HOSPICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031282 ↗
• MalfunctionJun 6, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S HEART RATE WAS IN THE THIRTY BEATS PER MINUTE RANGE AND THE PATIENT WAS EXPERIENCING DIZZINESS. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO A LOWER PACING RATE OF SIXTY BEATS PER MINUTE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 17072884 ↗
• InjuryMar 16, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE ANT I-TACHYCARDIA PACING ACCELERATED THE ARRHYTHMIA TO VENTRICULAR FIBRILLATION (VF) AND THE PATIENT WAS SUBSEQUENTLY TREATED WITH HIGH VOLTAGE THERAPY. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON THE TREATED EPISODE. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Ventricular Fibrillation

  MAUDE report 16553832 ↗
• InjuryOct 6, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POWER ON RESET (POR) DURING DEVICE INTERROGATION. THE CRT-D WAS RE-INTERROGATED AND THE RESET WAS CLEARED. THE CRT-D 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 10635436 ↗
• InjurySep 1, 2020Reset Problem; Reset Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A POWER ON RESET (POR) WITH A DEVICE INTERROGATION. THE CRT-D WAS "CLEARED" AND 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 10479655 ↗
• InjuryJun 26, 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 DUE TO INFECTION. A NEW LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10200784 ↗
• MalfunctionJun 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS ADDITIONALLY REPORTED, VIA FOLLOW UP, THAT THE PATIENT WAS SEEN IN CLINIC AND NORMAL DEVICE FUNCTION WAS NOTED. THE PATIENT MADE A REMOTE TRANSMISSION 2 WEEKS LATER AND THAT ALSO NOTED NORMAL DEVICE FUNCTION. THERE WAS NO PRODUCT PERFORMANCE ISSUE NOTED WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185613 ↗
• InjuryOct 24, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD PACING IMPEDANCES SUDDENLY DROPPED TO LOW IMPEDANCE. IT WAS DETERMINED THERE WAS A CIRCUIT ERROR ON THE DEVICE. THE DEVICE 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 9235594 ↗
• MalfunctionJan 15, 2019Electrical /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. THE DEVICE WAS INTERROGATED THREE DAYS LATER WITH THE SAME RESULT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8250654 ↗
• InjuryDec 21, 2018Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT'S DAUGHTER QUESTIONED IF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS WORKING PROPERLY. IT WAS FURTHER REPORTED THAT POST-IMPLANT THE PATIENT WAS "FEELING WEIRD" AND "FELT LITTLE ELECTRICAL PULSES." THE PATIENT BECAME CONCERNED WHEN THE ELECTRICAL PULSES WERE NO LONGER FELT. THE FAMILY MEMBER STATED THAT A REPORT INDICATED THAT THE PATIENT'S HEART HAD STOPPED AND A SHOCK OCCURRED; HOWEVER, THE FAMILY ALLEGES THAT NO SHOCK WAS PROVIDED. IT WAS ALSO REPORTED THAT THE PATIENT'S EJECTION FRACTION HAD INITIALLY IMPROVED, BUT HAS BEGUN TO DECLINE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8191444 ↗
• InjuryDec 4, 2018Adverse 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. THE PATIENT RECEIVED A NEW SYSTEM APPROXIMATELY TWO WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8130157 ↗
• InjuryNov 21, 2018Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT HAD ELECTRICAL STIMULATION AT THE CHIROPRACTOR AND ON THE WAY HOME "PASSED OUT". THE PATIENT HAD A DEVICE CHECK DONE AND STATED IT WAS "IN GOOD SHAPE". THE PATIENT'S SPOUSE IS WONDERING IF THE ELECTRICAL STIMULATION INTERFERED WITH THE DEVICE AND CAUSED THE PATIENT TO PASS OUT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 8095814 ↗
• InjuryAug 20, 2018Adverse 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 HAS BEEN EXTRACTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7799722 ↗
• MalfunctionJul 9, 2018Electrical /Electronic Property Problem; Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY VOLTAGE WAS BELOW INDICATION FOR IMPLANT. THE DEVICE WAS INTERROGATED TWO DAYS LATER WITH THE SAME RESULT. NO IMPLANT ATTEMPT WAS MADE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7670520 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT IMPLANT SITE. THE PATIENT WAS BROUGHT IN FOR A HEMATOMA EVACUATION. THE PHYSICIAN MADE A SEPARATE SMALL DISTAL INCISION AND DRAINED THE HEMATOMA. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Pain

  MAUDE report 7643038 ↗