BEUDAMED
    FDA Adverse Event Other Summary report: N

    VNS THERAPY PULSE

    MDR report key: 662708 · Received June 23, 2005

    Report

    Report Number
    1644487-2005-00404
    Event Type
    Other
    Date Received
    June 23, 2005
    Report Date
    May 26, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP WITH TREATING ENT SURGEON REVEALED THAT THE CAUSE OF THE GENERATOR "SLIPPING" WAS A BROKEN SUTURE, WHICH WAS INTENDED TO SECURE THE GENERATOR INTO PLACE. BECAUSE THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT RESULTED IN A SERIOUS INJURY, IT IS BELIEVED THAT THIS OCCURRENCE OF GENERATOR MIGRATION DOES NOT MEET THE REQUIRMENTS FOR MDR REPORTABILITY. THE DEVICE PERFORMED AS INTENDED AND NO DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    VNS PATIENT UNDERWENT REVISION SURGERY DUE TO DEVICE MIGRATION, AT WHICH TIME THE GENERATOR WAS RESECURED. DEVICE DIAGNOSITC TESTING APPROXIMATELY 2 1/2 WEEKS BEFORE REVISION SURGERY WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. THE DAY AFTER DEVICE DIAGNOSTIC TESTING WAS PERFORMED, THE PATIENT REPORTED TO HER NEUROLOGIST THAT SHE HAD A LUMP UNDER HER ARMPIT. X-RAYS WERE ORDERED, REVEALING DEVICE MIGRATION. INVESTIGATION HAS BEEN UNABLE TO DETERMINE THE CAUSE OF THE REPORTED DEVICE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 009493

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR