BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 1760855 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01618
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PT'S VNS PROGRAMMING PHYSICIAN REPORTED THAT HE HAD A PT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEMS TEST: OUTPUT STATUS - LIMIT, LEAD IMPEDANCE - HIGH, DCDC CONVERTER - 7, NEAR EOS = NO. THE PT IS MENTALLY DELAYED SO HE IS NOT CERTAIN THAT NO FALLS OR TRAUMAS HAVE OCCURRED, BUT NONE WERE REPORTED. THE PT'S CAREGIVERS DO NOT REPORT ANY CHANGE IN SEIZURE PATTERN. THE PT WAS LAST SEEN ON (B)(6) 2009, AND ALL DIAGNOSTICS WERE REPORTED TO BE WITHIN NORMAL LIMITS. THE PT WILL HAVE REVISION SURGERY, BUT A DATE IS NOT SET AT THIS TIME. THE PHYSICIAN'S PLANNED ON PROGRAMMING THEIR DEVICE OFF TILL SURGERY CAN BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5919

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR