Primo MRI™ VR SureScan™ DVMD3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000001551), received between Mar 9, 2020 and Dec 22, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (7 reports).

1 FDA recall record name this device's identifier, 1 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-1815-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23871446 ↗
• InjuryMar 31, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHICH RESULTED IN AN INAPPROPRIATE SHOCK AND ACCUMULATION OF SHORT V-VS AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS. 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 21731032 ↗
• InjuryJan 28, 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 SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21260367 ↗
• MalfunctionJan 6, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CLINICIAN ATTEMPTED TO SEND A TRANSMISSION FROM THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), HOWEVER RECEIPT OF A TRANSMISSION COULD NOT BE CONFIRMED.  IT WAS FURTHER REPORTED THAT THE REASON FOR THE ATTEMPTED TRANSMISSION WAS THAT THE PATIENT REPORTED TO THEIR CLINICIAN THAT THEIR ICD "STOPPED WORKING". 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 21081501 ↗
• InjuryMar 15, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INTERROGATION SHOWED PACING THERAPY AND DEFIBRILLATION SHOCKS WERE DELIVERED FOR EPISODES DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. IT WAS SUSPECTED THAT THE RHYTHM MAY HAVE BEEN RAPID VENTRICULAR RESPONSE WITH SUPRA VENTRICULAR TACHYCARDIA (SVT) IN PROGRESS AT THE TIME OF THERAPY, AND THERAPIES MAY HAVE BEEN INAPPROPRIATE. 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 18915311 ↗
• InjuryDec 14, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE HOSPICE HEALTHCARE PROFESSIONAL THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS "MALFUNCTIONING SINCE IT SHOCKED THE PATIENT TWICE". 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 18324419 ↗
• InjuryOct 5, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 17878381 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT UPON INTERROGATION PRIOR TO IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A GREY BAR FOR BATTERY LONGEVITY. THE ICD WAS NOT USED AND A NEW ICD WAS IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816418 ↗
• InjurySep 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR AN EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE IM PLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS LATER EXPLANTED AND REPLACED DUE TO AN UPGRADE TO A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BI-V ICD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17769728 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET EROSION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 16449270 ↗
• InjuryOct 10, 2022Adverse 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 AND REPLACED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15572487 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS POST IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14197877 ↗
• InjuryFeb 21, 2022Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH-RATE, NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC) AND IT WAS ADDITIONALLY NOTED THAT A SHOCK WAS DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THAT THESE OCCURRED DURING A SURGERY WHERE A MAGNET WAS NOT USED. 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 13568730 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 23 DAYS POST IMPLANT, THE POCKET INCISION HAD NOT HEALED DESPITE HAVE RECEIVED WOUND CARE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INDICATED TO HAVE BEEN VISIBLE OUTSIDE OF THE PATIENT'S BODY BEFORE THE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12759540 ↗
• InjuryJun 23, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR) AS A VENTRICULAR FIBRILLATION (VF) EPISODE. 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 12049798 ↗
• InjuryJan 5, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. PACING PAUSES WERE SEEN ON TELEMETRY WITH POSSIBLE RATES IN THE 20'S WERE WHICH WERE BELOW THE PROGRAMMED LOWER RATE OF 40 BEATS PER MINUTE. A REMOTE TRANSMISSION INDICATED THAT THE ICD WAS CURRENTLY FUNCTIONING AS PROGRAMMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dyspnea; Non specific EKG/ECG Changes

  MAUDE report 11120233 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED DUE TO INFECTION / BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9808865 ↗