BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1053197 · Received May 27, 2008

    Report

    Report Number
    1644487-2008-01232
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT WHILE VIEWING A VNS THERAPY PATIENT'S DIAGNOSTIC HISTORY ON HIS PRIOR PHYSICIAN'S PROGRAMMING HANDHELD, IT WAS NOTED THAT HIGH LEAD IMPEDANCE WAS OBTAINED DURING A DIAGNOSTIC TEST. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 40488C

    Patients

    Seq Age Sex Outcome Treatment
    1