BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1014129 · Received March 14, 2008

    Report

    Report Number
    1644487-2008-00705
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 1, 2006
    Report Date
    February 13, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT WILL UNDERGO EXPLANTATION OF HIS VNS THERAPY SYSTEM DUE TO FEELING THE LEAD WHEN HE TURNS HIS HEAD. X-RAYS WERE REVIEWED BY THE MANUFACTURER AND THE STRAIN RELIEF BEND DID NOT APPEAR TO BE ADEQUATE PER LABELING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other