Compia MRI Quad CRT-D SureScanRecalls & reported problems across all models

We found 4 models of Compia MRI Quad CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 199 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Aug 6, 2026 — classified as 6 deaths, 132 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (29 reports).

4 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Compia MRI Quad CRT-D SureScan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

2. 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 ↗

3. 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 ↗

4. 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 Compia MRI Quad CRT-D SureScan problems

Compia MRI Quad CRT-D SureScan models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths59 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 deaths69 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall56 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  15 reports

Recent Compia MRI Quad CRT-D SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 ↗

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