BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1031400 · Received April 18, 2008

    Report

    Report Number
    1644487-2008-00955
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. 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 SYSTEM DIAGNOSTICS ON A VNS PT RESULTED IN HIGH LEAD IMPEDANCE. THE PT HAD EXPERIENCED A FALL RECENTLY, BUT THE TREATING PHYSICIAN BELIEVED THAT IT DID NOT CONTRIBUTE TO THE EVENT. X-RAYS WERE PERFORMED AND SENT TO THE MANUFACTURER FOR REVIEW. NO OBVIOUS CAUSE FOR THE HIGH IMPEDANCE WAS FOUND. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30

    Patients

    Seq Age Sex Outcome Treatment
    1