BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1840044 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02101
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING THE PT'S F/U APPT, HIGH LEAD IMPEDANCE (8800 AND >10,000 OHMS) WAS OBSERVED DURING TWO DIAGNOSTICS PERFORMED. THE PT WAS TURNED ON AT THAT TIME AND WAS SCHEDULED FOR X-RAYS. THE PHYSICIAN DID NOT KNOW OF ANY TRAUMA TO THE AREA OF THE DEVICE. THE X-RAYS RECEIVED WERE REVIEWED BY THE MFR. BASED ON THE X-RAY RECEIVED, THERE WAS NO ANOMALY VISUALIZED THAT COULD HAVE BEEN CONTRIBUTING TO THE HIGH LEAD IMPEDANCE REPORTED. DUE TO THE LIMITED IMAGES AVAILABLE, THE LEAD BODY COULD NOT BE COMPLETELY ASSESSED. THE COMPANY REP VISITED WITH THE SITE AND DIAGNOSTICS APPEARED TO BE WITHIN NORMAL LIMITS, BUT SPECIFICS WERE NOT IMMEDIATELY AVAILABLE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR