BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYBERONICS-VAGUS NERVE STIMULATOR

    MDR report key: 2002813 · Received February 18, 2011

    Report

    Report Number
    MW5019490
    Event Type
    Death
    Date Received
    February 18, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2011
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER, (B)(6) , HAD A VNS IMPLANTED ON (B)(6) 2010. SHE WENT TO HER NEUROLOGIST ON (B)(6) 2010 AND HAD THE DEVICE TURNED ON. SHE DIED SUDDENLY ON (B)(6) 2010. IT IS MY BELIEF THAT THIS DEVICE WAS RESPONSIBLE FOR HER DEATH. THE MEDICAL EXAMINER REMOVED THE VNS DURING THE AUTOPSY AND SENT IT BACK TO THE MFR FOR DIAGNOSTICS. I ASKED THE MEDICAL EXAMINER IF I COULD HAVE THE DEVICE AND I WAS TOLD NO. I ASKED THAT THE DEVICE BE SENT TO A THIRD PARTY THAT WAS NOT INVOLVED SINCE I WAS NOT ALLOWED TO TAKE THE UNIT MYSELF. THE MFR IS CYBERONICS. THE SERIAL NUMBER IS: (B)(4), GENERATOR NUMBER: 17876 AND LEAD NUMBER 302. I DO NOT KNOW WHAT CYBERONICS DID WITH MY DAUGHTER'S DEVICE NOR HAVE I EVER RECEIVED ANY INFO WITH ANY FINDINGS. IT IS MY BELIEF THAT THE VNS CAUSED HER HEART TO STOP. SHE MEANT EVERYTHING TO ME AND SHE DIED LEAVING 2 CHILDREN WHO WERE ONLY 5 MONTHS AND 15 MONTHS OLD. IT IS MY HOPE THAT THIS DEVICE BE REMOVED FROM THE MARKET. I DO NOT CARE HOW MANY HAVE BENEFITED FROM USE OF IT, BECAUSE NO AMOUNT OF GOOD RESULTS ARE EVER WORTH SOMEONE'S LIFE. WE WERE NOT EVEN TOLD THAT THERE WAS A RISK OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS-VAGUS NERVE STIMULATOR VNS LYJ CYBERONICS 17876
    2 CYBERONICS-VAGUS NERVE STIMULATOR LEAD LYJ CYBERONICS 302

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death