BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ESSENTIALS KIT

    MDR report key: 1191915 · Received October 1, 2008

    Report

    Report Number
    1644487-2008-02379
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S MAGNET WAS CRACKED. GOOD FAITH ATTEMPTS TO OBTAIN PRODUCT RETURN FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT ESSENTIALS KIT LYJ CYBERONICS, INC. 220-3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR