Crome™ HF CRT-D MRI SureScan™ DTPC2D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00763000178291), received between Jun 21, 2021 and Jun 9, 2026 — classified as 1 death, 20 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (4 reports).

3 FDA recall records name this device's identifier, 3 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-1786-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 22, 2022Class IOpen, Classified

   There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

   Z-1490-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. Apr 12, 2022Class IIOpen, Classified

   Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

   Z-1268-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 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 25448860 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 24314306 ↗
• InjuryNov 20, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED VENTRICULAR TACHYCARDIA (VT) ALLOWED DUE TO WAVELET. 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 23609920 ↗
• InjuryOct 15, 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 AN INFECTION. THE ORGANISM WAS IDENTIFIED AS ENTEROCOCCUS FAECALIS. THE PATIENT EXPERIENCED FEVER, SEPSIS, AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Fever; Sepsis

  MAUDE report 23303760 ↗
• InjuryAug 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 APPROXIMATELY THREE WEEKS POST IMPLANT DUE TO A POCKET INFECTION WITH NOTED REDNESS AND SWELLING. UPON DEVICE INTERROGATION, IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS NOT CAPTURING. THE PATIENT RECEIVED ANTIBIOTICS. A TEMPORARY PACEMAKER WAS PLACED, AND ONE WEEK LATER THE SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 22717121 ↗
• MalfunctionJul 21, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHEN THE LEFT BUNDLE BRANCH PACING (LBBP) LEAD WAS CONNECTED TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERE WAS A NOTED CHANGE IN MORPHOLOGY SEEN ON THE SURFACE AND 12 LEAD ELECTROGRAMS (EGM) COMPARED TO THE ANALYZER. THE LEAD WAS DISCONNECTED AND TESTED WITH THE ANALYZER WITH NOTING THE NORMAL MORPHOLOGY INITIALLY DESIRED. TROUBLESHOOTING STEPS WERE PERFORMED AND THE ISSUE WAS RESOLVED. WHEN ATTEMPTING TO RECONNECT THE LEAD TO THE CRT-D HEADER IT WAS NOTED THAT THE SETSCREW BECAME STRIPPED. THE CRT-D WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560767 ↗
• InjuryJul 2, 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 AND REPLACED DUE TO INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, REDNESS, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 22384592 ↗
• InjuryJun 24, 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 REMOVED APPROXIMATELY TWO WEEKS POST-GENERATOR REPLACEMENT PROCEDURE DUE TO REDNESS AND SUSPECTED POCKET INFECTION. A NEW SYSTEM WAS IMPLANTED THE FOLLOWING WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 22322437 ↗
• InjuryMay 23, 2025Premature 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 22080854 ↗
• InjuryMar 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AND IT WAS EVACUATED. DURING THE EVACUATION PROCEDURE, THE PHYSICIAN DISCONNECTED THE LEADS FROM THE HEAD TO CLEAN THE LEADS. THE LEFT VENTRICULAR (LV) LEAD PORT SET SCREW BECAME DISCONNECTED FROM THE HEADER AND COULD NOT BE ENGAGED. THE SET SCREW CAME OUT OF THE HEADER WITH A SCREWDRIVER. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 21682593 ↗
• MalfunctionDec 27, 2024Pacing Problem; Inappropriate or Unexpected Reset; Pacing Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A DIAGNOSTIC ELECTRICAL RESET. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S WATCH CONSISTENTLY READS THEIR HEARTRATE IN THE FORTY BEATS PER MINUTE RANGE WHICH IS BELOW THE CRT-D PROGRAMMED LOWER RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21027118 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT MANY ORGANISMS WERE IDENTIFIED.

  Patient problems: Discomfort; Erosion; Erythema; Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20917071 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Damaged Thread; Mechanical Problem; Damaged Thread

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HEADER SETSCREW WAS DAMAGED. IT WAS NOTED THAT THE PHYSICIAN COULD NOT ENGAGE THE SETSCREW, AND THAT THE SETSCREW WAS SIDEWAYS IN THE PORT AND THE THREADS WERE DAMAGED/STRIPPED. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787066 ↗
• MalfunctionSep 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL EMERGENCY DEPARTMENT AND EMERGENCY MEDICAL SERVICES (EMS) REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. 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 20163015 ↗
• InjuryAug 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION WAS PERFORMED APPROXIMATELY 2 WEEKS POST IMPLANT TO CORRECT THE LOOSE SET SCREW AND RIGHT VENTRICULAR (RV) LEAD CONNECTOR PIN CONNECTION ISSUE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD 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 19991242 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT, THE PATIENT DEVELOPED A POSSIBLE INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19711538 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS POST-CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT, THE PATIENT DEVELOPED A SEPTIC INFECTION AND WENT INTO SEPTIC SHOCK. THE PATIENT HAD A FEVER AND PURULENT DISCHARGE/PUS. THE CRT-D SYSTEM WAS EXPLANTED AND APPROXIMATELY TWO WEEKS LATER, A NEW SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Purulent Discharge; Sepsis; Septic Shock

  MAUDE report 19221840 ↗
• InjuryJan 12, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS ALSO NOTED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF) AND MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VF. IT WAS REPORTED THAT A MAGNET WAS PLACED ON THE DEVICE. THE DEVICE AND RV 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 18504586 ↗
• InjuryOct 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE CRT-D WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17934348 ↗
• DeathSep 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD FOLLOWING A RECENT DEVICE CHANGE OUT PROCEDURE. THE LV LEAD EXHIBITED CHRONIC HIGH THRESHOLDS WHICH CAUSED POSSIBLE PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LV LEAD WAS REPROGRAMMED AND THEN LV LEAD WAS CAPPED AND REPLACED. THE CRT-D WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LV LEAD HAD IMPEDANCE ISSUES. ADDITIONALLY, AFTER THE PLACEMENT OF THE CRT-D AND LV LEAD REPLACEMENT, SIX DAYS LATER MULTIPLE ISSUES RESULTED IN NEED FOR SURGERY AND THE FOLLOWING DAY THE PATIENT DIED. THE PRIMARY CAUSE OF DEATH LISTED AS CEREBRAL INFARCTION AND SECONDARY CAUSE OF DEATH LISTED AS RESPIRATORY FAILURE.

  Patient problems: Respiratory Failure; Stroke/CVA

  MAUDE report 17670038 ↗
• InjuryMar 29, 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 EXPLANTED DUE TO INFECTION AND POCKET EXPOSURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16637022 ↗
• MalfunctionMar 15, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING BRADYCARDIA BECAUSE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROVIDING PACING BELOW THE LOWER PROGRAMMED RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16547429 ↗
• InjuryAug 1, 2022Unable to Obtain Readings; Missing Test Results; Unable to Obtain Readings; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS STUCK IN A NON-WIRELESS TELEMETRY SESSION. THE DEVICE WAS INTERROGATED, AND THE PERSISTENT SESSION ACTIVE FLAG WAS CLEARED USING A NON-BLUETOOTH TELEMETRY SESSION. 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 15142178 ↗
• InjuryJul 29, 2022Unable to Obtain Readings; Missing Test Results; Unable to Obtain Readings; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS STUCK IN A NON-WIRELESS TELEMETRY SESSION. THE DEVICE WAS INTERROGATED, AND THE PERSISTENT SESSION ACTIVE FLAG WAS CLEARED USING A NON-BLUETOOTH TELEMETRY SESSION. 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 15133235 ↗
• MalfunctionApr 15, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED A VENTRICULAR TACHYCARDIA (VT) EPISODE AS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 14119218 ↗