BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1001066 · Received February 22, 2008

    Report

    Report Number
    1644487-2008-00379
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS THERAPY PATIENT "MAY NEED THE LEAD WIRE REPLACED." THE WIRE IS "NOW VISIBLE THRU SKIN, STRETCHED TIGHT ACROSS CHEST." THE PHYSICIAN REVIEWED X-RAYS AND "WIRES APPEAR INTACT." DIAGNOSTIC TESTING YIELDED GOOD RESULTS IN 2008. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1300

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other