Crome™ DR MRI SureScan™ DDPC3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000178437), received between Nov 20, 2020 and Sep 25, 2026 — classified as 1 death, 39 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (16 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-1728-2023 · 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50902936 ↗
• InjuryJun 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE OR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS ADDITIONALLY REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A POSSIBLE EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS AN EPISODE OF MONITORED VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. THE LEAD AND DEVICE 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 25653622 ↗
• InjuryJun 26, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT MAY HAVE EXPERIENCED POSSIBLE INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) MIS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING OBSERVED ON STORED EPISODES. THE RA LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 25635494 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25375569 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia

  MAUDE report 24901290 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS AN INCIDENT THAT THE PATIENT A BLOOD INFECTION AND THE DEFIBRILLATOR WIRES GOT INFECTED. A SURGERY WAS PERFORMED TO REMOVE THE ENTIRE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24650001 ↗
• MalfunctionMar 3, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AS MONITORED VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ELEVATED AND HIGH THRESHOLDS. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND IMPEDANCE VARIATION. THE ICD, RA LEAD, AND RV LEAD WERE SUBSEQUENTLY REPLACED DUE TO A SYSTEM UPGRADE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500263 ↗
• MalfunctionFeb 18, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A MONITORED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH FAST VENTRICULAR RESPONSE. 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 24381641 ↗
• MalfunctionFeb 11, 2026Electrical /Electronic Property Problem; Reset Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD EXPERIENCED A RESET PRIOR TO IMPLANT AND DISPLAYED A GRAY BATTERY LONGEVITY BAR AFTER IT WAS DROPPED ON THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313826 ↗
• InjuryNov 14, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF). REVIEW OF THE ELECTROGRAM (EGM) SUGGESTS THAT THE EPISODE WAS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO 1:1 CONDUCTION. THE ICD 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 23555631 ↗
• InjuryNov 12, 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 INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR FIBRILLATION (VF). THE ICD 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 23533355 ↗
• InjuryOct 24, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WERE POSSIBLE INSTANCES OF INAPPROPRIATE WITHHOLDING OF THERAPIES FOR VENTRICULAR TACHYCARDIA (VT)/FAST VENTRICULAR TACHYCARDIA (FVT) BY THE SUPRAVENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR. SEVERAL EPISODES OF VT/FVT WERE APPROPRIATELY TREATED, WHILE SVT EPISODES APPEARED SIMILAR TO VT/FVT AT TIMES, RAISING CONCERNS ABOUT POSSIBLE INAPPROPRIATE WITHHOLDING OF THERAPIES. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23380807 ↗
• MalfunctionAug 15, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD ALERTED FOR UNDEFINED HIGH PACING IMPEDANCE ON THE DATE OF THE GENERATOR CHANGE. TWO YEARS LATER, THE RV LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCE AND UNDEFINED HIGH RV PACING IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, A SHARP RISE IN RV COIL IMPEDANCE, AND OUT OF RANGE (OOR) HIGH COIL IMPEDANCE. IT WAS NOTED THAT THE RV LEAD HAD A RV COIL FRACTURE. THE RV LEAD WAS EXPLANTED AND REPLACED. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED TO MAKE THE REMOVAL OF THE RV LEAD EASIER. IT WAS NOTED THAT ON THE DAY OF THE LEAD REPLACEMENT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AT RIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES THAT SHOWED NON-PHYSIOLOGIC RATES AND MORPHOLOGIES CONSISTENT WITH ELECTROCAUTERY NOISE. 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 22819426 ↗
• InjuryJun 24, 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 WITH COMPETITOR LEADS WAS EXPLANTED EIGHT MONTHS POST IMPLANT DUE TO AN INFECTION INVOLVING REDNESS AND BACTEREMIA. THE ICD SYSTEM WAS REPLACED FOUR DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Erythema; Unspecified Infection

  MAUDE report 22319465 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 21969843 ↗
• MalfunctionMar 19, 2025Device Alarm System; Device Alarm System

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS TESTED AND TONES WERE CONFIRMED TO BE WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645548 ↗
• InjuryFeb 26, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE INAPPROPRIATE THERAPY FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE, WHICH WAS SUSPECTED TO BE A JUNCTIONAL RHYTHM. THE ICD 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 21470706 ↗
• MalfunctionFeb 21, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A PATIENT'S HEART RATE DECREASED TO 40 BEATS PER MINUTE (BPM), AND NO NOTIFICATION WAS RECEIVED ON THE MYCARELINK (MCL) HEART APPLICATION. THE PATIENT'S SPOUSE MENTIONED THAT THE PATIENT UNDERGOES DIALYSIS THREE TIMES A WEEK. DURING A DIALYSIS SESSION, THE NURSE MONITORED THE PATIENT'S VITALS, INCLUDING BLOOD PRESSURE AND HEART RATE, EVERY 15 MINUTES. THE NURSE ADVISED CONTACTING THE DEVICE MANUFACTURER FOR FURTHER ASSISTANCE. THE PATIENT WAS EDUCATED ON THE MCL HEART APPLICATION AND REFERRED TO A HEART CLINIC FOR MEDICAL INQUIRIES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21437806 ↗
• InjuryJan 21, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY WITHHELD THERAPY FOR VENTRICULAR FIBRILLATION (VF). THE DEVICE CLASSIFIED THE EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21199699 ↗
• InjuryJan 13, 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 ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) WITH AN ATRIAL ARRHYTHMIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 21139657 ↗
• InjuryJan 7, 2025Signal Artifact/Noise; Mechanical Problem; Device Sensing Problem; Signal Artifact/Noise; Mechanical Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AS THE PHYSICIAN WAS CLOSING THE POCKET, THERE WAS INCONSISTENT SIGNALS AND NON-PHYSIOLOGIC NOISE SEEN ON THE ATRIAL CHANNEL. THE POCKET WAS REOPENED, AND THE LEAD WAS DISCONNECTED FROM THE DEVICE HEADER. THE LEAD WAS TESTED WITH THE ANALYZER, AND ALL LOOKED NORMAL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RE-BURPED, AND THE ATRIAL LEAD TIP WAS CLEANED AND RE-INSERTED. THE ISSUE IMPROVED, BUT INTERMITTENT NOISE REMAINED. IT WAS SUSPECTED THAT THERE WAS FLUID OR AIR TRAPPED IN THE DEVICE HEADER. THE ICD WAS REMOVED AND REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093906 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED BY THE PATIENT THAT, "IT LASTED ABOUT A MONTH AND THEN SWELLED UP LIKE A FAT HOG <(>&<)> IT WAS INFECTED AND I GOT A BLOOD INFECTION AND I HAVE IV'S IN ME FOR ANOTHER 2 WEEKS."

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

  MAUDE report 20903791 ↗
• InjuryNov 27, 2024Adverse 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 HAD VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20801176 ↗
• InjuryNov 13, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE SHOCKS FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT) AS AN EPISODE OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WAS IN PROGRESS DURING THE HIGH-VOLTAGE THERAPY EPISODE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 20675812 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. DURING EXTRACTION OF ONE OF THE PREVIOUSLY CAPPED LEADS, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20526034 ↗