BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1022117 · Received March 25, 2008

    Report

    Report Number
    1644487-2008-00776
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 29, 2008
    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 THAT DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE AT A ROUTINE OFFICE VISIT. THE REPORTER STATED THAT THERE WAS NO KNOWN TRAUMA THAT MAY HAVE CAUSED THE HIGH LEAD IMPEDANCE. X-RAYS HAVE NOT BEEN TAKEN. THE DEVICE WAS PROGRAMMED OFF. IT IS UNK IF REVISION SURGERY WILL OCCUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1