BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1963425 · Received December 20, 2010

    Report

    Report Number
    1644487-2010-02852
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 BY A NURSE THAT DIAGNOSTIC TESTS RESULTED IN HIGH LEAD IMPEDANCE DURING AN OFFICE VISIT FOR A VNS PT. THE NURSE STATED THAT THERE WAS NO KNOWN TRAUMA THAT MAY HAVE CAUSED THE HIGH IMPEDANCE. THE VNS PT UNDERWENT FULL REVISION SURGERY AND THE PRODUCTS, GENERATOR AND LEAD, WERE RETURNED TO THE MFR WHERE PRODUCT ANALYSIS IS UNDERWAY. ADD'L INFO FROM THE NEUROSURGEON'S OFFICE INDICATED NO X-RAYS WERE ORDERED AND THEY WERE NOT AWARE OF ANY PT MANIPULATION OR TRAUMA TO THE DEVICE. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MFR AND ARE CURRENTLY UNDERGOING PRODUCT ANALYSIS. (B)(4) ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING NURSE HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 2185

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR