BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1790307 · Received August 6, 2010

    Report

    Report Number
    1644487-2010-01820
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT HAD HIGH LEAD IMPEDANCE READINGS WITH SYSTEMS DIAGNOSTICS TESTING AT AN OFFICE VISIT. THE VNS WAS DISABLED. NO ADVERSE PT EVENTS WERE REPORTED. THE PT HAD NO KNOWN TRAUMA. X-RAYS WERE RECEIVED AND REVIEWED BY THE MFR. NO OBVIOUS LEAD ANOMALIES WERE IDENTIFIED, BUT THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER, RULING OUT A PIN ISSUE AND MAKING A LEAD FRACTURE SCENARIO MORE LIKELY. VNS REVISION SURGERY APPEARS LIKELY. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1