BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1891027 · Received October 29, 2010

    Report

    Report Number
    1644487-2010-02438
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HIGH IMPEDANCE ON DIAGNOSTICS. THE PT HAS BEEN NEARLY SEIZURE-FREE SINCE IMPLANT. X-RAYS WERE REVIEWED BY THE MFR AND IT WAS NOTED THAT THE PIN MAY NOT BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK, THOUGH BASED ON THE ANGLE OF THE IMAGES, THIS COULD NOT BE CONFIRMED. NO OTHER ANOMALIES WERE VISUALIZED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1