Crome™ VR MRI SureScan™ DVPC3D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000178536), received between Mar 30, 2021 and Sep 24, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 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-1822-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888558 ↗
• InjuryDec 3, 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 AND REPLACED DUE TO INFECTION WITH VEGETATION NOTED AT THE LOCATION OF THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT EXPERIENCED WOUND DEHISCENCE, DISCOMFORT, PAIN, REDNESS AND PURULENT DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Wound Dehiscence

  MAUDE report 23711031 ↗
• InjuryNov 18, 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 REMOVED DUE TO POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23589859 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED INTERMITTENT UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGMS). THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH HYPERTENSION WITH FOURTEEN INAPPROPRIATE SHOCKS IN SETTING OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WITH ANOTHER EPISODE OF APPROPRIATE SHOCK IN SETTING OF POLYMORPHIC VENTRICULAR TACHYCARDIA (VT) AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT END OF SERVICE (EOS). THE ICD WAS EXPLANTED AND REPLACED AND THE PATIENT RECEIVED A ATRIO-VENTRICULAR NODAL ABLATION PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: High Blood Pressure/ Hypertension; Shock from Patient Lead(s)

  MAUDE report 23057704 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PUS AND DRAINAGE. A POCKET INFECTION WAS SUSPECTED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET WAS REVISED AND CLEANED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Purulent Discharge; Unspecified Infection

  MAUDE report 22537949 ↗
• InjuryMay 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-GENERATOR CHANGE, DURING THE WOUND CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED RV COIL AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES. IN ADDITION, THE TIP TO COIL IMPEDANCE WAS OBSERVED TO BE HIGH AS WELL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT INTO THE CATH LAB AND REATTACHMENT OF THE LEAD CONNECTORS TO THE HEADER WAS PERFORMED AND THE PROBLEM WAS SOLVED. THE LEAD TESTED NORMALLY THROUGH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A DEFIBRILLATION THRESHOLDS (DFT) WAS PERFORMED NORMALLY. THE DEVICE AND RV LEAD 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 19387973 ↗
• InjuryAug 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYNCOPE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DELIVERED INAPPROPRIATE THERAPY FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) BUT THE RHYTHM WAS DETECTED 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); Syncope/Fainting

  MAUDE report 17571178 ↗
• InjuryApr 26, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS AND WAS ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS ADMINISTERED OXYGEN AND CAME BACK AROUND. IT WAS NOTED THAT THE PATIENT HAD A SIMILAR EPISODE THE DAY BEFORE BEING ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT¿S PULSE RATE WAS BRADYCARDIC BELOW THE PROGRAMMED LOWER RATE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 16819642 ↗
• MalfunctionDec 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT CAUSED IT TO BE UNABLE TO COMMUNICATE WITH THE REMOTE MONITOR NETWORK. 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 15972392 ↗
• InjuryAug 15, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS DETERMINED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT) CAUSED BY FENTANYL INGESTION, AND IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF SHOCKS DUE TO FENTANYL-INDUCED SVT. 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 15229692 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE ICD IMPLANT SITE. THE ICD IMPLANT SITE NEVER HEALED AND CLOSED AFTER IMPLANT AND HAS BEEN DRAINING FLUID WHICH IS NOW CLOUDY. THE ICD SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14610986 ↗
• MalfunctionMar 30, 2021Inappropriate 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 11588536 ↗