BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1052076 · Received May 20, 2008

    Report

    Report Number
    1644487-2008-01148
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT A SITE BELIEVED THEIR PROGRAMMING WAND WAS CAUSING COMMUNICATION PROBLEMS. ALL TROUBLESHOOTING ATTEMPTS DID NOT RESOLVE THE ISSUE. A NEW PROGRAMMING WAND WAS SENT TO THE SITE. GOOD FAITH ATTEMPTS TO OBTAIN THE OLD PROGRAMMING WAND FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1