BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1923717 · Received December 9, 2010

    Report

    Report Number
    1644487-2010-02772
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROSURGEON THAT A VNS PT WHOM SHE WILL BE PERFORMING LEAD REVISION SURGERY, HAD LEFT LARYNGEAL PALSY AND SWALLOWING DIFFICULTIES. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE. FURTHERMORE, PER THE TREATING SURGEON INTERVENTION WILL BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention