Crome DR MRI SureScanRecalls & reported problems across all models

We found 2 models of Crome DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2020 and Sep 25, 2026 — classified as 1 death, 50 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (17 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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

Crome DR MRI 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, 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. 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 ↗

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

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

Most reported Crome DR MRI SureScan problems

Crome DR MRI SureScan models

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

• Crome™ DR MRI SureScan™ DDPC3D4

  Pulse generator, permanent, implantable
  3 recalls1 death52 reports
• Crome™ DR MRI SureScan™ DDPC3D1

  Pulse generator, permanent, implantable
  3 recalls16 reports

Recent Crome DR MRI SureScan adverse event reports

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

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls