BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1800097 · Received August 10, 2010

    Report

    Report Number
    1644487-2010-01831
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 13, 2006
    Report Date
    July 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    RPTR INDICATED A PT HAD LOW IMPEDANCE READINGS WITH VNS SYSTEMS AND NORMAL MODE DIAGNOSTICS, SUGGESTING A POSSIBLE LEAD ISSUE. THE PT HAD PREVIOUSLY HAD NORMAL IMPEDANCE READINGS IN (B)(6) 2005. THE PT CANNOT COMMUNICATE IF VNS STIMULATION IS FELT AS SHE IS NONVERBAL. DISABLING THE VNS WAS RECOMMENDED AND SURGICAL EVAL WAS PLANNED. FURTHER FOLLOW-UP REVEALED THE RPTR HAS BEEN UNSUCCESSFUL IS BEING ABLE TO CONTACT THE PT'S FAMILY TO DISCUSS THE PLAN OF CARE. AS A RESULT, X-RAYS HAVE NOT BEEN PERFORMED AND THE VNS HAS NOT BEEN DISABLED. THE RPTR WILL CONTINUE TO TRY AND REACH THE FAMILY TO DISCUSS THE PT'S PLAN OF CARE WITH THE VNS AND REPORT BACK TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 5986

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR