BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1123808 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01927
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2002
    Report Date
    July 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    AN IMPLANT CARD WAS RECEIVED FOR A VNS PATIENT'S GENERATOR REVISION SURGERY THAT OCCURRED DUE TO GENERATOR END OF SERVICE. ON THE IMPLANT CARD, LEAD IMPEDANCE WAS MARKED "HIGH." FOLLOWUP WITH THE PATIENT'S TREATING PHYSICIAN REVEALED THAT THE PATIENT HAS HIGH LEAD IMPEDANCE READINGS FOR A WHILE. HOWEVER, AS THE PATIENT HAS NOT EXPERIENCED ANY PROBLEMS AND IS RECEIVING EFFICACY FROM VNS THERAPY, THERE ARE NO PLANS TO REVISE THE PATIENT'S LEAD.

    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