BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA DYSTONIA THERAPY

    MDR report key: 6158961 · Received December 9, 2016

    Report

    Report Number
    6158961
    Event Type
    Death
    Date Received
    December 9, 2016
    Date of Event
    October 30, 2016
    Report Date
    December 7, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    MRU
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEATH AT HOME. PT WITH DBS IMPLANTED. PER MOM, PT WAS SICK, HAVING TROUBLE KEEPING OXYGEN SATURATION ABOVE 92%. PT STARTED TO HYPERVENTILATE AND EMS WAS CALLED. WHEN EMS ARRIVED, PT STOPPED BREATHING AND WENT INTO CARDIAC ARREST. WE WERE UNABLE TO REVIVE HIM. PER MOM, "HE WENT QUICKLY, WITHOUT PAIN." DBS LEADS WERE PLACED ON (B)(6) 2015, MEDTRONIC 3387S 40 CM ELECTRODES, LOT # VA0KQXQ. RC IPG WAS PLACED ON (B)(6) 2015, ACTIVA RC 37612 PULSE GENERATOR, SN # (B)(4). ON (B)(6) 2015, TWO ADD'L ELECTRODES WERE PLACED IN BILATERAL VIM NUCLEUS. PER PI, PT DIED OF RESPIRATORY FAILURE DUE TO UNDERLYING DISEASE. PER PI, THIS AT HOME DEATH IS UNRELATED TO THE DBS IMPLANT. IT IS HOWEVER, RELATED TO HIS UNDERLYING DISEASE. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813047 ACTIVA DYSTONIA THERAPY DEEP BRAIN STIMULATOR (DBS) MRU MEDTRONIC ACTIVA RC 37612 VA0KQXQ

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death CLONIDINE| DEPAKENE| NEXIUM| PHENOBARBITAL| SINGULAIR| ZANTAC