BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2431111 · Received January 24, 2012

    Report

    Report Number
    MW5024009
    Event Type
    Injury
    Date Received
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - UNKNOWN
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ST. JUDE MEDICAL IMPLANTABLE DEFIBRILLATOR MODEL NUMBER ICD 1207-36, (B)(4), IMPLANTED (B)(6) 2009. RVA MODEL NUMBER 712160, (B)(4). SHOCKED ME THREE (3) TIMES WITHIN 20 MINUTE PERIOD. HOSPITAL TURNED OFF ICD AND REPLACED LEAD WITH TWO NEW LEADS AND A NEW DOUBLE LEAD DEFIBRILLATOR. WAS TOLD THERE WAS NOTHING WRONG WITH MY HEART, JUST THE PRODUCT. REASON FOR USE: HEART FAILURE, CABG X5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL IMPLANTABLE DEFIBRILLATOR LWS ST. JUDE MEDICAL - UNKNOWN 1207-36 UNKNOWN
    2 ST. JUDE MEDICAL LEAD LWS ST. JUDE MEDICAL - UNKNOWN 7121/60 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization