BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 597132 · Received April 18, 2005

    Report

    Report Number
    597132
    Event Type
    Other
    Date Received
    April 18, 2005
    Date of Event
    April 15, 2005
    Report Date
    April 18, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    10 MEDTRONIC ICDS REPLACED THAT WERE INVOLVED IN RECALL. THESE WERE REPLACED BETWEEN 4/05 AND 4/05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ICD NIK MEDTRONIC, INC. 7277 *
    2 * ICD LWS MEDTRONIC, INC. 7274 *
    3 * ICD NIK MEDTRONIC, INC. 7289 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN