BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 6947809 · Received October 13, 2017

    Report

    Report Number
    3002250546-2017-00006
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    February 16, 2017
    Report Date
    October 13, 2017
    Manufacturer
    FHC, INC
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT WAS NOT CAUSED BY FHC'S PRODUCT MP-KIT-P-BI.

    Description of Event or Problem · 1

    FHC'S CUSTOMER DEVELOPMENT SPECIALIST BECAME AWARE OF AN ADVERSE EVENT ON SEPTEMBER 24TH 2017. THE ADVERSE EVENT HAD OCCURRED ON (B)(6) 2017 AT (B)(6) HOSPITAL. FHC'S MP-KIT-P-BI WAS USED IN DEEP BRAIN STIMULATION SURGERY. DURING THE SURGERY, THERE WAS AN ACTIVE DEEP BRAIN BLEED DUE TO WHICH THE SURGERY HAD TO BE ABORTED AND THE PATIENT SUFFERED LEFT SIDE PARALYSIS AND FACIAL PALSY. THE DEEP BRAIN BLEED WAS NOT CAUSED BY MP-KIT-P-BI SINCE IT IS A NON-INVASIVE FOUR LEGGED PLATFORM WHICH PROVIDES GUIDANCE IN THE POSITIONING OF ELECTRODES. THE PATIENT HAS RELIEF FROM 70% OF SYMPTOMS AND HAS FACIAL DROOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728312 WAYPOINT STEREOTACTIC SYSTEM MICROTARGETING PLATFORM HAW FHC, INC MP-KIT-P-BI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization