BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAGAL NERVE STIMULATOR

    MDR report key: 1276206 · Received December 30, 2008

    Report

    Report Number
    MW5009482
    Event Type
    Other
    Date Received
    December 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    December 30, 2008
    Manufacturer
    CYBERONICS, INC
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON HAS MICROCEPHALY WITH SPASTIC QUADRIPLEGIA. HE IS NONVERBAL AND REQUIRES TOTAL CARE. HE HAD INCREASED SEIZURE ACTIVITY WHILE IN THE HOSPITAL FOR SPINAL ROD PLACEMENT, AND HIS VAGAL NERVE STIMULATOR WAS "TURNED UP" TO TRY AND HELP WITH THIS. HE WENT HOME UNEVENTFUL AND IN FACT A DAY EARLY AND HAD 2 MORE VISITS TO THE NEURO FOR ADJUSTMENT OF THE VNS. BY APPROX TWO MONTHS LATER, PT DEVELOPED SEVERE BREATHING PROBLEMS, ERRATIC HEART RATES 45-152/MIN, LOSS OF HIS VOICE WHEN HE CRIED AND PROFUSE SWEATING. HE ENDED UP REQUIRING CONSTANT NASAL OXYGEN WITH A NONREBREATHER AT TIMES. HE NOW ALSO REQUIRES CPAP AT NIGHT AND DAILY BREATHING TREATMENTS. I TAPED THE MAGNET ONTO THE VNS THE FOLLOWING MONTH TO SHUT IT OFF, BECAUSE HIS DOCTOR DIDN'T BELIEVE IT WAS THE VNS...IF I HADN'T OF DONE THIS, MY SON WOULD BE DEAD TODAY. I AM A RN AND AM APPALLED AT THE LACK OF CARING AND KNOWLEDGE R/T THIS DEVICE. I TOOK HIM BACK TO THE SURGEON THAT PUT IT IN AND HE TURNED THE DEVICE DOWN TO THE ORIGINAL SETTINGS. AT THE HIGHEST POINT, IT WAS ON FOR 30 SEC AND OFF FOR .8 MIN WITH 2.5 AMP. IT IS NOW ON FOR 30 SEC AND OFF FOR 5 MIN AT 1.75 AMP. DATES OF USE: 2007 -- 2008. DIAGNOSIS OR REASON FOR USE: SEIZURES. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGAL NERVE STIMULATOR VNS THERAPY LYJ CYBERONICS, INC 102

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other