BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2150727 · Received June 17, 2011

    Report

    Report Number
    1644487-2011-01376
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S VNS INDICATED HIGH IMPEDANCE AND HE COULD NOT FEEL STIMULATION. IT WAS ALSO NOTED THAT THE PT'S SEIZURES ARE WORSENING. SURGERY TO REPLACE THE PT'S VNS LEAD AND GENERATOR HAS OCCURRED. A MANUFACTURER REP PRESENT AT THE SURGERY INDICATED THAT A LEAD FRACTURE WAS OBSERVED NEAR THE GENERATOR. THE PT'S LEAD AND GENERATOR WILL LIKELY BE RETURNED HOWEVER, THEY HAVE NOT BEEN RECEIVED TO DATE. 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 7565C

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention