BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1212558 · Received October 27, 2008

    Report

    Report Number
    1644487-2008-02580
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 29, 2007
    Report Date
    October 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAS EXPERIENCED VOCAL CORD PARALYSIS ON THE LEFT VOCAL CORD SINCE IMPLANTATION TILL 2008. IT WAS DETERMINED BY THE PHYSICIAN THAT THE EVENT IS DEFINITELY RELATED TO IMPLANTATION AND NOT RELATED TO STIMULATION. NO ACTIONS WERE TAKEN FOR THIS EVENT. REVIEW OF PROGRAMMING HISTORY REVEALED PROPER DEVICE FUNCTION. THE ROOT CAUSE OF THE REPORTED EVENT HAS BEEN DETERMINED TO BE THE IMPLANTATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1925

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability