BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY

    MDR report key: 970371 · Received December 25, 2007

    Report

    Report Number
    MW5004789
    Event Type
    Injury
    Date Received
    December 25, 2007
    Date of Event
    December 24, 2006
    Report Date
    December 25, 2007
    Manufacturer
    CYBERONICS, INC
    Product Code
    MUZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAGAL NERVE STIMULATOR IMPLANTED IN 2006; SCAR/MRSA INFECTION OCCURRED ON THE FOLLOWING MONTH; RE-IMPLANTED ON FOUR DAYS LATER; DEVICE WAS HANGING OUT OF MY BODY IN 2007; REMOVED ON THAT DAY; DEVELOPED 2 UNHEALING WOUNDS AT INCISION SITES. ON THREE MONTHS LATER, A 4-5" LONG HARD, HOLLOW TUBE POPPED OUT OF ONE OF THE INCISIONS FULL OF PUS; SURGERY THE SAME DAY, MY BIRTHDAY, BY THE WAY. SINCE THREE MONTHS EARLIER HAVE HAD A BLOODY, PUS-FILLED OPEN HOLE IN MY NECK; SCHEDULED 5TH SURGERY FOR A MASSIVE GRANULOMA IN 2008. I AM NOW BEING BILLED BY THE COMPANY, ALTHOUGH WAS SELECTED FOR AN FDA-APPROVED REGISTRY, AND TOLD IT WAS OF NO CHARGE, NOTHING WAS EVER SIGNED, EXCEPT ONE WEEK BEFORE WHEN I SIGNED THAT I WAS AWARE OF THE 2% INFECTION RATE AND AM ON DISABILITY. NEITHER THE FDA OR CYBERONICS, INC HAS RELEASED INFO PERTAINING TO WHAT COULD GO WRONG WITH THIS DEVICE, WHAT HAPPENS IF INFECTION IS PRESENT, ETC. PERSONS HAVE DIED FROM THIS DEVICE, DESPITE THE FACT THAT 28 MEMBERS OF THE BOARD DID NOT AGREE THAT THE VAGAL NERVE STIMULATOR WAS A "SAFE & EFFECTIVE TREATMENT FOR TREATMENT-RESISTANT-DEPRESSION. IT WAS STILL APPROVED IN JUNE, 2006. I BELIEVE THE PRODUCT WAS DEFECTIVE; BUT WHEN REQUESTING THE DEVICE TO SEND IT SOMEWHERE ELSE; IT WAS IMMEDIATELY SENT BACK TO "CYBERONICS, INC.", AS WELL AS THE TUBE. I BELIEVE THIS IS CALLED, 'SPOLIATION OF EVIDENCE' AND IT IS AGAINST THE LAW. I BELIEVE THERE IS SOMETHING GOING ON THAT IS CERTAINLY NOT LEGAL BETWEEN THE COMPANY & THE FDA IN REGARDS TO THIS DEVICE AND SOMETHING NEEDS TO BE DONE ABOUT IT. THE DR WHO IS SURGICALLY REPAIRING THE NEUROSURGEON'S BLATANT BOTCHED SURGERIES, PLURAL... INDICATED TO ME THAT THERE ARE STILL FOREIGN DEVICES AROUND MY VAGAL NERVE; WAS NEVER TOLD BY "CYBERONICS, INC.", THE FDA OR MEDICAL SYSTEM THAT INFO BEFORE, DURING OR AFTER THESE EVENTS. DOSE OR AMOUNT: WAND INCREASING. FREQUENCY: EVERY 2 WEEKS. ROUTE: OTHER. DATES OF USE: 2006. DIAGNOSIS: TREATMENT-RESISTANT-DEPRESSION. EVENT ABATED AFTER USE STOPPED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 MO Hospitalization| O| R| S VAGUS NERVE STIMULATOR