BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2030806 · Received March 4, 2011

    Report

    Report Number
    1644487-2011-00409
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL IMPLANT SURGERY, THE PHYSICIAN USED ELECTROCAUTERY NEAR THE VNS GENERATOR CAUSING IT TO BE DISABLED. A BACK-UP GENERATOR HAD TO BE IMPLANTED. A MFR REP WAS PRESENT AT THE SURGERY AND CAUTIONED THE SURGEON PRIOR TO THE SURGERY ON THE USE OF ELECTROCAUTERY. ATTEMPTS FOR THE RETURN OF THE DISABLED GENERATOR ARE CURRENTLY IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2839

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR