BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMIPULSE GEN MODEL 103

    MDR report key: 1913922 · Received November 30, 2010

    Report

    Report Number
    1644487-2010-02695
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE COMPANY REP THAT THE PHYSICIAN INFORMED HER THAT THE PT WAS RECENTLY IMPLANTED AND NOW HAD VOCAL CORD PARALYSIS (VCP). SHE STATED THAT THE PT IS PROGRAMMED ON TO LOW SETTINGS. THE TREATING PHYSICIAN BELIEVES THE REASON IS LIKELY DUE TO SURGEON AND THE IMPLANT PROCEDURE. FOLLOW UP WITH THE COMPANY REP REVEALED THAT NO INTERVENTION IS PLANNED OR TAKEN AT THE MOMENT AND THE PT IS GOING TO SEE AN ENT. THEY BELIEVE THE PARALYSIS IS RELATED TO THE SURGERY AS THE PT SHOWED VCP RIGHT AFTER THE SURGEON PRIOR TO EVEN TURNING THE DEVICE ON. THEY TURNED THE DEVICE ON A FEW DAYS AFTER THE SURGERY AND THE PT WAS SET AT THE LOWEST SETTINGS. THE PHYSICIAN WAS NOT SURE IF PARALYSIS WAS TEMPORARY OR PERMANENT. COMPANY REP STATED THAT THE PHYSICIAN HAS NOT PERFORMED ANY DIAGNOSTICS AS THE PT IS AT LOW SETTINGS AND THEY DID WANT TO DO IT RIGHT NOW. COMPANY REP ALSO STATED THAT SHE WAS PRESENT IN THE SURGERY AND DIAGNOSTICS THAT TIME WAS FINE WITH EVERYTHING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMIPULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2709

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention