Crome™ DR MRI SureScan™ DDPC3D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000178413), received between Feb 17, 2021 and Apr 9, 2026 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 16, 2026.

Recalls naming this device

1. May 10, 2023Open, 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-1727-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 22, 2022Open, 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-1489-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. Apr 12, 2022Open, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM), TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENTS AT TIMES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE LEAD AND DEVICE WERE EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832356 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION WAS NOTED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED LOW BLOOD PRESSURE DURING THE EXPLANT PROCEDURE. THE EXPLANT PROCEDURE WAS ABORTED AND COMPLETED AT A LATER TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 21930131 ↗
• MalfunctionDec 11, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT AFTER AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCES. THE 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 20904245 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20893933 ↗
• InjuryNov 27, 2024Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797649 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION, FEVER, AND PURULENT DISCHARGE/PUS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 20740820 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED APPROXIMATELY TWO MONTHS POST IMPLANT, DUE TO A POCKET EROSION INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19773305 ↗
• InjuryJul 3, 2024Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR RIGHT VENTRICULAR (RV) LEAD WAS ¿FRAYED¿. THE PATIENT INDICATED THAT THEIR PREVIOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY ¿EXHAUSTED BECAUSE OF THE LEAD¿ AND WAS EXPLANTED AND REPLACED. THE PATIENT REPORTED THE RV LEAD WAS ¿ALREADY SUCKING UP A LOT OF THE BATTERY¿ OF THE REPLACEMENT ICD. THEY NOTED THAT ADJUSTMENTS WERE MADE ¿SO IT DOESN¿T SUCK UP AS MUCH ENERGY¿ BUT INDICATED THAT AS A RESULT OF THE PROGRAMMING CHANGES ¿THE PACEMAKER WAS NOT WORKING AS GOOD AS IT SHOULD¿. THE PATIENT REPORTED FEELING SHORT OF BREATH AND SCARED. THE RV LEAD AND REPLACEMENT ICD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Emotional Changes

  MAUDE report 19666952 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A BACTEREMIA INFECTION (ENTEROCOCCUS FAECALIS), WITH VEGETATION ON THE TRICUSPID AND AORTIC VALVES, AND THE LEADS. THE INFECTION IS BELIEVED TO HAS ORIGINATED IN THE POCKET AND SPREAD DOWN THE LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 19645894 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT EXPERIENCED PAIN, DISCOMFORT, REDNESS, SWELLING AND DRAINAGE AT THE IMPLANT SITE. THREE DAYS LATER A NEW ICD SYSTEM WAS IMPLANTED ON THE OTHER SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 18503740 ↗
• MalfunctionNov 1, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT REVIEW OF HIGH-RATE NON-SUSTAINED EPISODES SHOWED OVERSENSING AND NOISE ON BOTH THE RIGHT ATRIAL AND VENTRICULAR CHANNELS THAT WAS CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SOURCE OF THE EMI WAS UNKNOWN. THE ICD 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 18051865 ↗
• MalfunctionOct 31, 2023High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS AN ISSUE WITH THE SUPERIOR VENA CAVA (SVC) PORT SET SCREW ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEADER. THE SETSCREW WAS LOOSE AND COULD NOT ENGAGE OR BE TURNED. THE SETSCREW DISENGAGED FROM THE THREADS AND WAS SIDEWAYS IN THE PORT. THE SETSCREW CAME OUT OF THE HEADER CONNECTED TO THE WRENCH AND WHEN ATTEMPTING TO RE-ENGAGE THE SETSCREW, THE SETSCREW WOULD NOT ¿CLICK¿ ON THE LEAD AND TESTING SHOWED THAT THE HIGH VOLTAGE IMPEDANCE WAS HIGH. THE ICD WAS REMOVED AND A NEW ICD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040783 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND BLOOD CULTURES WERE POSITIVE FOR KLEBSIELLA OXYTOCA AND STREPTOCOCCUS  GALLOLYTICUS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 17432535 ↗
• MalfunctionNov 23, 2021Missing Test Results; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICDS) ESTIMATED BATTERY LONGEVITY DISPLAYED AS A SERIES OF QUESTION MARKS RATHER THAN A NUMERICAL VALUE ON THE INTERROGATION REPORT. THE ICD 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 12865365 ↗
• MalfunctionMar 11, 2021Electrical /Electronic Property Problem; Missing Test Results; Electrical /Electronic Property Problem; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD NO BATTERY LONGEVITY DATA OR CAPTURE MANAGEMENT TRENDS SINCE THE LAST REMOTE TRANSMISSION. IT WAS NOTED THAT THE DEVICE WAS STUCK IN A TELEMETRY MODE. 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 11464273 ↗
• InjuryFeb 17, 2021Inappropriate or Unexpected Reset; Output Problem

  IT WAS FURTHER REPORTED THAT AFTER THE RESET, THE LONGEVITY ESTIMATE SHOWED AS "???". IT WAS NOTED THAT THIS WAS DUE TO A REMOTE TRANSMISSION SENT AFTER THE RESET WAS DONE PRIOR TO THE NEXT BATTERY VOLTAGE MEASUREMENT OF THE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338110 ↗