BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1033462 · Received April 23, 2008

    Report

    Report Number
    1644487-2008-00987
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INITIAL RPTR INDICATED THAT HE WAS SENDING BACK A SERIAL CABLE BECAUSE "THE CORD WAS CAUSING INTERMITTENT COMMUNICATION." HE KNEW IT WAS THE SERIAL CABLE BECAUSE HIS WORKED WITH THE SYSTEM BUT THE PHYSICIAN'S DID NOT. A MALFUNCTION IS SUSPECTED AGAINST THE SERIAL CABLE. THE SERIAL CABLE IS AT MANUFACTURE PENDING COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521383

    Patients

    Seq Age Sex Outcome Treatment
    1