Crome™ HF CRT-D MRI SureScan™ DTPC2D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000178307), received between Mar 24, 2021 and Jan 20, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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-1785-2023 · 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SEND A REMOTE TRANSMISSION, AND TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PATIENT WAS REFERRED TO THEIR CLINIC FOR A DEVICE CHECK. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120420 ↗
• MalfunctionJan 13, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A TONE AND NOTED IT COULD BE A ¿BATTERY LIFE CONCERN OR A LEAD MIGHT HAVE BEEN MISALIGNED.¿ THE CRT-D AND LEFT VENTRICULAR (LV) 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 24056953 ↗
• InjuryNov 4, 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. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS BLOOD BORNE. DISCOMFORT, EROSION, PAIN, REDNESS, AND VEGETATION OF THE TRICUSPID VALVE WERE ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 23465695 ↗
• InjuryApr 24, 2025Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGER DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND HIGH SENSING INTEGRITY COUNTER (SIC). RECORDED EPISODES SHOW CLEAR EVIDENCE OF NOISE ON TIP TO RING ELECTROGRAMS (EGM). THE HEALTHCARE PROFESSIONAL WAS UNABLE TO REPRODUCE THE NOISE, BUT DID SEE A NON-PHYSIOLOGIC VARIATION IN IMPEDANCES WHEN DOING SERIAL IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT GIVEN THE RECENT GENERATOR CHANGE, THE ISSUE WAS LIKELY DUE TO A LEAD/HEADER CONNECTION ISSUE. DETECTIONS WERE TURNED OFF AND THE LEAD WAS LATER CAPPED AND REPLACED. 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 21903746 ↗
• MalfunctionAug 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SETSCREW COULD NOT BE TURNED AND THERE WAS A SETSCREW/WRENCH INTERFACE PROBLEM. IT WAS ALSO NOTED THAT THE PIN PLUG WAS PLACED IN THE SUPERIOR VENA CAVA (SVC) PORT AND THEN JAMMED. A DIFFERENT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977031 ↗
• MalfunctionMay 22, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER TIGHTENING THE LEADS INTO THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IT WAS DEEMED NECESSARY TO UNSCREW AND RETIGHTEN ONE OF THE SET SCREWS. UPON UNSCREWING AND RETIGHTENING THE PHYSICIAN WAS THEN UNABLE TO REALIGN SET SCREW AS IT BECAME DISENGAGED WITH THE THREADING WITHIN THE HEADER OR WAS STRIPPED. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981230 ↗
• InjuryFeb 28, 2023High impedance; Loose or Intermittent Connection; Mechanical Problem; Device Contamination with Body Fluid; High Capture Threshold; High impedance; Loose or Intermittent Connection; Mechanical Problem; Device Contamination with Body Fluid; High Capture Threshold

  IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND HIGH, UNDEFINED IMPEDANCES. IT WAS DETERMINED THAT THE RV LEAD HAD MOVED IN THE HEADER, POSSIBLY DUE TO THE CRT-D SET SCREW MIGRATING. THE LEAD WAS REMOVED AND RE-INSERTED INTO THE HEADER. IT WAS NOTED THAT BLOOD WAS IN THE CRT-D HEADER AT THE TIME OF THE REVISION. 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 16453109 ↗
• InjuryDec 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS THERE WAS CHRONICALLY HIGH THRESHOLD ON THE EPICARDIAL LEFT VENTRICULAR (LV) LEAD THAT LEAD TO PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LV LEAD WAS CAPPED AND REPLACED WITH A TRANSVENOUS LEAD. 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 15981654 ↗
• InjuryMay 7, 2022Failure 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) INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO THE ALGORITHM DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF AN SVT ORIGIN. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 14323795 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND ENDOCARDITIS. BLOOD CULTURES WERE NEGATIVE. THE SYSTEM WAS REMOVED AND THE PATIENT WAS PACED WITH A TEMPORARY SYSTEM UNTIL A NEW SYSTEM WAS IMPLANTED A FEW DAYS POST-EXTRACTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 13168844 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEADS WERE EXPOSED AND A POCKET REVISION WAS PERFORMED. NEARLY TWO MONTHS LATER A LARGE DEHISCENCE WITH PURULENT DRAINAGE AT THE POCKET AND AN INFECTION WAS NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON ANTIBIOTICS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THE PATIENT WAS DISCHARGED WITH A LIFE VEST. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 13019004 ↗
• MalfunctionMar 25, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) LONGEVITY ESTIMATE HAD INCREASED BY SEVERAL YEARS AND THEN RETURNED TO THE APPROXIMATE INITIAL ESTIMATE. NO SIGNIFICANT PROGRAMMING CHANGES OR THERAPIES HAD TAKEN PLACE TO REFLECT SUCH DIFFERENCES IN LONGEVITY. 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 11568191 ↗
• InjuryMar 24, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A LOOSE SETSCREW ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CAUSING HIGH UNDEFINED PACING IMPEDANCE ON THE HIS BUNDLE LEAD. THE PATIENT REPORTEDLY EXPERIENCED SHORTNESS OF BREATH. A PROCEDURE WAS PERFORMED TO TIGHTEN DOWN THE SETSCREW SECURELY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 11561357 ↗