BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1944037 · Received December 29, 2010

    Report

    Report Number
    1644487-2010-02919
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED HIGH LEAD IMPEDANCE DURING A ROUTINE OFFICE VISIT. THE PT WAS REFERRED FOR AND UNDERWENT A FULL REVISION IN WHICH THE LEAD AND GENERATOR WERE EXPLANTED AND REPLACED DUE TO THE HIGH LEAD IMPEDANCE READINGS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AS WELL AS THE EXPLANTED LEAD AND GENERATOR FOR PRODUCT ANALYSIS ARE CURRENTLY BEING MADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR