Crome™ VR MRI SureScan™ DVPC3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000178550), received between Nov 19, 2020 and Apr 15, 2026 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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-1823-2023 · 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-1489-2022 · 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE ICD AND RV LEAD WERE EXPLANTED DUE TO INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24887751 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION WITH PAIN, REDNESS, AND SWELLING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23609814 ↗
• InjuryMay 1, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY WITHHELD THERAPY INAPPROPRIATELY FOR EPISODES OF VENTRICULAR TACHYCARDIA (VT) BY THE ONSET DISCRIMINATOR. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ICD WAS REPROGRAMMED.

  Patient problems: Tachycardia

  MAUDE report 21942577 ↗
• InjuryJan 31, 2025Adverse 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 THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TEMPORARY LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21282552 ↗
• InjuryNov 7, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. THE HEALTH CARE PROFESSIONAL (HCP) STATED THE DEVICE SHOCKED THE PATIENT AS THEY WERE BEING BROUGHT TO THE HOSPITAL. THERE WAS NO ARRYTHMIA NOTED SINCE THE LAST INTERROGATION. NO ADDITIONAL INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Shock from Patient Lead(s)

  MAUDE report 20629839 ↗
• InjurySep 5, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EVENTUALLY INTUBATED FOR VF STORM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683673 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17605546 ↗
• InjuryJul 11, 2023Inappropriate/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 OF FAST VENTRICULAR TACHYCARDIA (FVT) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE(RVR). 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 17298621 ↗
• MalfunctionApr 26, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 16820176 ↗
• InjuryApr 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS LOOSE IN THE POCKET AND HAD MIGRATED TO THE PATIENT¿S ARMPIT. THE PATIENT REPORTS DISCOMFORT RELATED TO THE DEVICE MIGRATION AND HAD BEEN MOVING IT BACK AS NEEDED. THE DEVICE WAS REVISED AND REIMPLANTED. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR HIGH DEFIBRILLATOR COIL IMPEDANCE. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16736962 ↗
• InjuryJan 10, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT WITHHOLD TREATMENT AND THE WAVELET DID NOT MATCH; THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR VENTRICULAR TACHYCARDIA (VT). THE DEVICE 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 16130639 ↗
• InjuryDec 13, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCK ENERGY THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT WAS LESS THAN PROGRAMMED. THE DEVICE SHORT CIRCUIT PROTECTION (SCP) TRUNCATED THE ENERGY DELIVERED. THE DEVICE WAS REPROGRAMMED AND 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 15970319 ↗
• MalfunctionNov 10, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS ¿FALLING OUT¿ OF THE CHEST PREVENTING THE PATIENT FROM WEARING A GARMENT. 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 15776805 ↗
• InjuryMar 1, 2022Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS DETECTED AS A SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE WAVELET DETECTION ALGORITHM WITHHELD FOR SVT BUT MATCH SCORES ONLY SHOWED ONE OUT OF EIGHT MATCHING AND SHOULD HAVE DELIVERED THERAPY FOR THE VT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 13637389 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12391833 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION/EROSION THREE WEEKS AFTER THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH AN ABSORBABLE ENVELOPE. THE ICD SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11366543 ↗
• MalfunctionDec 18, 2020Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF FATIGUE, AND THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dyspnea; Fatigue

  MAUDE report 11037133 ↗
• MalfunctionNov 19, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE INDICATED THAT THE DEVICE EXHIBITED A PARTIAL POWER ON RESET (POR). 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 10868231 ↗