BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1940651 · Received December 17, 2010

    Report

    Report Number
    1644487-2010-02839
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    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 CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE COMPANY REP THAT THE PT'S NEW GENERATOR COULD NOT BE INTERROGATED IN THE OPERATING ROOM DURING INITIAL IMPLANT SURGERY. IT WAS OBSERVED IN THE OPERATING ROOM THAT THE HANDHELD HAD A BAD CONNECTION AND WAS CAUSING THE FAILURE TO PROGRAM EVENT. NEW PROGRAMMING SYSTEM WAS SHIPPED TO THE COMPANY REP AND HER OLD SYSTEM WAS RETURNED FOR ANALYSIS. ANALYSIS WAS COMPLETED ON THE HANDHELD AND THE REPORTED ALLEGATION WAS VERIFIED. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE SYNC CABLE CONNECTOR ON THE BOTTOM OF THE HANDHELD WAS DAMAGED. THE CAUSE FOR THE DAMAGE TO THE CONNECTOR COULD NOT BE DETERMINED BASED ON THE RETURNED HANDHELD. HOWEVER, BASED ON THE DAMAGED CONNECTOR, IT IS MOST LIKELY ASSOCIATED WITH MISHANDLING OF THE DEVICE AS IT APPEARS THE CONNECTOR DETENTS ARE NOT BEING COMPRESSED WHEN REMOVING OR MANIPULATING THE SERIAL DATA CABLE, THUS PLACING AN EXTENSIVE AMOUNT OF FORCE ON THE PCB AND ATTACHED CABLE RECEPTACLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 584960

    Patients

    Seq Age Sex Outcome Treatment
    1