BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-V ICD

    MDR report key: 1083412 · Received July 20, 2008

    Report

    Report Number
    1083412
    Event Type
    Malfunction
    Date Received
    July 20, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 20, 2008
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO END-OF-LIFE GENERATOR ISSUES. INTERROGATION OF THE PATIENT'S MEDTRONIC BI-V ICD SHOWED A BATTERY VOLTAGE OF 2.61 V, WHICH REACHED THE ELECTIVE REPLACEMENT INDICATION (ERI). THE CHARGE TIME WAS 10.4 SECONDS. IN SUMMARY, THE PATIENT'S MEDTRONIC BI-V ICD HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR AND THEREFORE, HE WAS SCHEDULED FOR AN ICD GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-V ICD GENERATOR, AICD LWS MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT 7289 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR