BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1063655 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01433
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED A PT UNDERWENT VNS THERAPY SYSTEM REPLACEMENT SURGERY. DURING THE SURGERY THE LEAD WAS REPLACED. THREE DIAGNOSTIC TESTS WERE PERFORMED "PRIOR TO CLOSING THE PATIENT, BUT ONCE THEY CLOSED THE PT, KEPT GETTING A HIGH LEAD IMPEDANCE." THE PT WAS REOPENED AND THE PHYSICIAN MOVED THE LEAD DOWN THE NERVE TO AN AREA WHERE THERE WAS NO SCAR TISSUE, BUT STILL KEPT GETTING A HIGH LEAD IMPEDANCE. ADDITIONAL TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND THE NEWLY IMPLANTED LEAD WAS REPLACED. THE LEAD HAS BEEN RETURNED TO THE MFR AND IS PENDING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1985

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR