BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1133587 · Received August 19, 2008

    Report

    Report Number
    1644487-2008-01954
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REPORTED THAT THE VNS PT'S DEVICE SHOWED HIGH IMPEDANCE DURING A DIAGNOSTIC TEST. THE GENERATOR WAS TURNED OFF AT THE LAST VISIT WHEN HIGH IMPEDANCE WAS SEEN. NO PT MANIPULATION OCCURRED ACCORDING TO THE PHYSICIAN. X-RAYS WERE TAKEN AND THE PT WAS SENT FOR A SURGICAL CONSULTATION. AS A RESULT OF THE CONSULTATION, THE SURGEON DECIDED TO REPLACE THE LEAD. X-RAYS WERE REVIEWED BY THE MFR AND NO ANOMALIES WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE EVENT. NO LEAD BREAK WAS OBSERVED IN SURGERY, BUT THE SURGEON WENT ON AND PERFORMED THE LEAD REVISION. THE EXPLANTED LEAD HAS BEEN RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 7272

    Patients

    Seq Age Sex Outcome Treatment
    1