BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1022730 · Received March 27, 2008

    Report

    Report Number
    1644487-2008-00803
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THE PT UNDERWENT GENERATOR REPLACEMENT SURGERY FOR NORMAL END OF SERVICE. ONCE THE NEW GENERATOR WAS IMPLANTED, SYSTEM DIAGNOSTICS SHOWED HIGH LEAD IMPEDANCE. THE NEW GENERATOR WAS TESTED AND "WAS WORKING FINE." THE PHYSICIAN DID NOT HAVE CONSENT TO REPLACE THE LEAD; THEREFORE, THE LEAD WAS NOT EXPLANTED. THE PHYSICIAN PLANS TO WAIT 6 MONTHS BEFORE POSSIBLE REVISION SURGERY, AS THE PT'S MOTHER DOES NOT BELIEVE THE PT NEEDS VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 1164

    Patients

    Seq Age Sex Outcome Treatment
    1