BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 437905 · Received December 30, 2002

    Report

    Report Number
    437905
    Event Type
    Malfunction
    Date Received
    December 30, 2002
    Date of Event
    September 25, 2002
    Report Date
    November 14, 2002
    Manufacturer
    METRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAULTY/MALFUNCTIONING INTERNAL CARDIAC DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD PULSE GENERATOR LWS METRONIC, INC. 7229 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR