BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 1940143 · Received December 23, 2010

    Report

    Report Number
    1644487-2010-02891
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, 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 PT HAD HIGH IMPEDANCE ON SYSTEM AND NORMAL MODEL DIAGNOSTICS. THE PT HAS BEEN SEIZURE-FREE FOR A LONG TIME. X-RAYS WERE TAKEN AND REVIEWED BY THE MANUFACTURER WHICH REVEALED NO OBVIOUS ANOMALIES. THE GENERATOR WAS TURNED OFF AND REVISION SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 8280

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR