BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2102249 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01116
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    December 14, 2009
    Report Date
    April 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PATIENT HAD HIGH IMPEDANCE, DCDC=7. PATIENT'S DEVICE WAS DISABLED AND NO SURGERY HAS BEEN SCHEDULED YET. PATIENT IS DOING FINE PER TREATING NEUROLOGIST. ADDITIONALLY, THE PHYSICIAN REPORTED THAT DEVICE PROGRAMMING HISTORY DID NOT RECORD THE MAGNET SWIPES. ONLY PATIENT'S INITIALS WERE PROVIDED TO THE MANUFACTURER AND GOOD FAITH ATTEMPTS TO OBTAIN MORE INFORMATION 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 17 YR Unknown