BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 1002808 · Received February 26, 2008

    Report

    Report Number
    1644487-2008-00388
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IMPLANT AND WARRANTY REGISTRATION CARD RECEIVED AT MANUFACTURER REPORTING THE PT HAD PROPHYLACTIC GENERATOR REPLACEMENT AND LEAD REPLACED FOR LEAD DISCONTINUITY. THERE WAS NO REPORT OF A FALL, INJURY OR INTERACTION WITH THEIR VNS LEAD SITE PRECEDING THE LEAD DISCONTINUITY. A GROSS LEAD FRACTURE WAS NOT SEEN IN THE OR DURING THE REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR PRODUCT RETURN AND ADDITIONAL INFO SURROUNDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5213

    Patients

    Seq Age Sex Outcome Treatment
    1