BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE ICD

    MDR report key: 2170637 · Received July 6, 2011

    Report

    Report Number
    MW5021366
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ST JUDE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST BELIEVES DEVICE FAILED BEFORE IT WAS EXPECTED TO. "BATTERY LIFE SHORTER THAN EXPECTED." ASKS FOR REPORT TO BE MADE IN CASE OTHERS HAVE HAD SAME EXPERIENCE. ICD WAS UPGRADED TO BIVENTRICULAR ICD FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE ICD ICD DUAL CHAMBER NIK ST JUDE V-365

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R