BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1063601 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01423
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE PHYSICIAN WAS EXPERIENCING PROBLEMS USING THE PROGRAMMING WAND. THEY HAD TO TWIST THE CORD AROUND AND HOLD IT IN A CERTAIN WAY FOR THE DEVICE TO FUNCTION. THE PROGRAMMING WAND HAS BEEN RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING WAND LYJ CYBERONICS, INC. 201 22752

    Patients

    Seq Age Sex Outcome Treatment
    1