BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1081546 · Received July 25, 2008

    Report

    Report Number
    1644487-2008-01697
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTES TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS NOT ABLE TO INTERROGATE A PT WITH ONE OF THEIR PROGRAMMING SYSTEMS. THE POWER LIGHT AND THE DATA RECEIVED LIGHT WAS NOT LIT WHEN USING THE PROGRAMMING WAND. THEY USED ANOTHER PROGRAMMING SYSTEM AND IT WORKED. THE SERIAL ADAPTER CABLE WAS SWITCHED OUT AND ATTACHED TO THE MALFUNCTIONING HANDHELD AND WAND. A SUCCESSFUL INTERROGATION WAS ABLE TO BE PERFORMED ON A DEMONSTRATION GENERATOR WHEN THE PROGRAMMING WAND WAS FLIPPED OVER. PRODUCT ANALYSIS WAS PERFORMED ON THE PROGRAMMING WAND. THE SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, HAD AN INTERMITTENT CONDUCTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1