BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1052079 · Received May 20, 2008

    Report

    Report Number
    1644487-2008-01177
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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 PHYSICIAN RECEIVED A COMMUNICATION FAILURE WHEN TRYING TO PERFORM INITIAL PROGRAMMING FOR A NEWLY IMPLANTED VNS PT. TROUBLESHOOTING RULED OUT ANY ISSUES WITH THE PROGRAMMING SYSTEM. THE PHYSICIAN INDICATED THE PT HAS BEEN REFERRED TO NEUROSURGERY FOR GENERATOR EVAL. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1