BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT

    MDR report key: 563864 · Received November 15, 2004

    Report

    Report Number
    MW1034099
    Event Type
    Injury
    Date Received
    November 15, 2004
    Date of Event
    July 23, 2004
    Report Date
    November 15, 2004
    Manufacturer
    GUIDANT CORP
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AICD PLACEMENT THREE YEARS AGO AND WAS FOUND TO HAVE NOISE IN THE LEADS. OVER SENSING ON V LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT AICD LEADS AND GENERATOR LWS GUIDANT CORP 4244 *
    2 GUIDANT AICD LEADS AND GENERATOR LWS GUIDANT CORP 0145 *
    3 GUIDANT AICD LEADS AND GENERATOR LWS GUIDANT CORP 1831 AV111 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R