BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 590789 · Received April 1, 2005

    Report

    Report Number
    590789
    Event Type
    Other
    Date Received
    April 1, 2005
    Date of Event
    March 9, 2005
    Report Date
    April 1, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VOLUNTARY RECALL OF DEVICE. THE DECISION WAS MADE TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD GENERATOR LWS MEDTRONIC, INC. 7278 *
    2 * ICD GENERATOR LWS MEDTRONIC, INC. 7274 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWNREPLACED DUE TO VOLUNTARY RECALL