BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1350812 · Received December 31, 2008

    Report

    Report Number
    1644487-2008-03126
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Date of Event
    November 19, 2008
    Report Date
    December 4, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT HAD NEVER FELT STIMULATION SINCE SHE WAS IMPLANTED, EVEN AT HIGH SETTINGS. VNS DIAGNOSTICS WERE NORMAL. DURING STIMULATION, IT WAS NOTED THAT THE PATIENT'S LEFT EYE WOULD TEAR AND THE PUPIL WOULD DILATE. THE PATIENT ALSO HAD DECREASED VISUAL ACUITY. THE REPORTER FELT THE VNS LEAD WAS POSSIBLY ON THE WRONG ANATOMICAL STRUCTURE OR ON THE VAGUS NERVE IN SUCH A WAY THAT PROPER STIMULATION WAS NOT POSSIBLE. THE PATIENT HAS ALSO NOT HAD ANY EFFICACY FOR HER DEPRESSION SINCE THE VNS WAS INITIALLY IMPLANTED, BUT HER DEPRESSION IS NOT WORSE THAN BEFORE THE VNS WAS IMPLANTED. THE PATIENT UNDERWENT LEAD REVISION SURGERY AND NOW FEELS STIMULATION. ATTEMPTS FOR RETURN OF THE EXPLANTED LEAD ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1937

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention