BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORIN OVATIO ICD VR-IMPLANTED

    MDR report key: 9848022 · Received March 17, 2020

    Report

    Report Number
    MW5093814
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    March 13, 2020
    Report Date
    March 15, 2020
    Manufacturer
    SORIN CRM SAS
    Product Code
    MRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED 5 SHOCKS; A (B)(6) FEMALE WITH HOCM WITH SEVERE MR S/P IMPLANTABLE ICD (VVI) FOR SUSTAINED VFIB. PT EXPERIENCED THE ICD FIRING MULTIPLE SHOCKS LASTING 10 MINS. AT THIS TIME OF EVENT, SHE REPORTED DIZZINESS ANXIETY, SHORTNESS OF BREATH AND CHEST PAIN. NO SYMPTOMS HAD BEEN EXPERIENCED OF THIS ICD SINCE IT WAS IMPLANTED IN 2011. THE LAST TIME THE ICD WAS INTERROGATED WAS (B)(6) 2020. AT THE TIME, THE PT WAS TOLD THAT THE BATTERY LIFE WAS AT 3% AND CANNOT BE CHANGED UNTIL IT IS COMPLETELY DEAD AS INSURANCE WILL NOT PAY FOR IT. WHILE AT THE HOSP, SHE WAS TAKEN FOR CARDIAC CATHETERIZATION WHICH SHOWED NO SIGNIFICANT OBSTRUCTIVE DISEASE. HER ICD WAS FURTHER INTERROGATED BY THE MFR WHICH REVEALED LEAD CONDUCTOR FRACTURE WITH BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR. SHE WAS INFORMED A NEW ICD WITH NEW LEADS WILL BE NEEDED. A LIFEVEST WAS ORDERED FOR THE PT AS A TEMPORARY SOLUTION UNTIL A DECISION IS MADE BY THE FAMILY AS THEY CONSULT WITH PRIMARY PHYSICIAN, CARDIOLOGISTS AND ELECTROPHYSIOLOGIST ON THE APPROPRIATE TREATMENT AND STEPS FOR THE PT. ALL INDICATION OF PT EXPERIENCE IS THE FRACTURED OF THE ICD LEAD WHICH CAUSED THE MALFUNCTIONING OF THE DEVICE TO SHOCK THE PT MULTIPLE TIMES AND CAUSING HER TO BE HOSPITALIZED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307238 SORIN OVATIO ICD VR-IMPLANTED DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM SAS 350053/6250

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| O| R| S