BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1900333 · Received October 26, 2010

    Report

    Report Number
    1644487-2010-02411
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    February 12, 2007
    Report Date
    September 28, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    REPORTER INDICATED A VNS PT HAD HIGH LEAD IMPEDANCE THAT WAS FIRST NOTED ON (B)(6) 2007. THE VNS WAS DISABLED ON THIS DATE, BUT WAS THEN TURNED BACK ON. THE PT WAS SENT FOR X-RAYS, AND HAD VNS LEAD AND GENERATOR REVISION SURGERY PERFORMED. ATTEMPTS FOR FURTHER INFO AND RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC 300-20 5316

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR