BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEM

    MDR report key: 718884 · Received May 3, 2006

    Report

    Report Number
    718884
    Event Type
    Other
    Date Received
    May 3, 2006
    Date of Event
    February 23, 2006
    Report Date
    May 3, 2006
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC VOLUNTARY RECALL. ICD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM ICD LWS MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT 7276 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR