BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1810819 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00537
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT HAD HIGH LEAD IMPEDANCE THAT WAS DISCOVERED DURING GENERATOR REPLACEMENT SURGERY. THE PT HAD NO TRAUMA AND DID NOT MANIPULATE THE VNS. THE PT'S OLD GENERATOR HAD PREVIOUSLY BEEN EXPLANTED APPROX TWO YRS EARLIER FOR LACK OF EFFICACY AND THE LEADS WERE LEFT IN PLACE. THE PT WAS ORIGINALLY IMPLANTED WITH VNS FOR AN OFF-LABEL INDICATION FOR ATOMIC SEIZURES AND SHE WAS A POOR RESPONDER TO VNS; SHE HAS SINCE HAD A CORPUS CALLOSOTOMY AND NOW HAS PARTIAL-ONSET SEIZURES WHICH MAY RESPOND TO VNS THERAPY. THE EXPLANTED LEAD IS CURRENTLY IN PRODUCT ANALYSIS. THE FORMERLY EXPLANTED GENERATOR HAS BEEN REQUESTED FOR RETURN. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 9895C

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR