BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1070006 · Received July 2, 2008

    Report

    Report Number
    1644487-2008-01518
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 4, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 THAT THE POWER ADAPTER CORD IS LOOSE AND THE ONLY WAY TO GET THE HANDHELD TO CHARGE IS TO MANUALLY HOLD THE ADAPTER CORD INTO THE WALL OUTLET. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN. PRODUCT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521426

    Patients

    Seq Age Sex Outcome Treatment
    1