BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ESSENTIALS KIT

    MDR report key: 1022735 · Received March 27, 2008

    Report

    Report Number
    1644487-2008-00800
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS MAGNET WAS NOT ELICITING A MAGNET MODE STIMULATION DURING A MAGNET MODE TEST DUE TO THE MAGNET BEING CRACKED. ALL ATTEMPTS FOR FURTHER INFO AND MAGNET 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