BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2030477 · Received March 9, 2011

    Report

    Report Number
    1644487-2011-00455
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    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 A VNS PT HAD HIGH LEAD IMPEDANCE WITH SYSTEMS DIAGNOSTICS TESTING. THE VNS WAS DISABLED. THE PT HAD NO KNOWN TRAUMA. NO X-RAYS WERE PERFORMED. THE PLAN OF CARE IS TO OBSERVE THE PT CLINICALLY WITH THE VNS DISABLED FOR NOW, AS THE PT IS SEIZURE-FREE. IF SEIZURES INCREASE, VNS REPLACEMENT SURGERY MAY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 26924C

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR