BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2031147 · Received March 16, 2011

    Report

    Report Number
    1644487-2011-00569
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    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

    A VNS PROGRAMMING NURSE IN (B)(6) REPORTED TO OUR COUNTRY REP THAT THEY HAD A PT WITH HIGH LEAD IMPEDANCE. IT WAS REPORTED THE PT HAD BEEN IMPLANTED FOR SEVEN YEARS AND PRESENTED IN CLINIC WITH HIGH LEAD IMPEDANCE . THE PT IS GOING TO BE SENT FOR X-RAYS. IT IS UNK IF THEIR VNS HAS BEEN PROGRAMMED OFF. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    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