BEUDAMED
    FDA Adverse Event Death Summary report: N

    FHC MICROELECTRODE

    MDR report key: 8388293 · Received March 4, 2019

    Report

    Report Number
    3002250546-2019-00002
    Event Type
    Death
    Date Received
    March 4, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 3, 2019
    Manufacturer
    FHC, INC,
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED FOR EVALUATION. NO INDICATION OF DEVICE MALFUNCTION. MICROELECTRODE RECORDING (MER) INVOLVES THE USE OF STERILE METAL PROBES WHICH ARE INSERTED INTO THE BRAIN DURING SURGERY. THIS MAY CAUSE HEMORRHAGE WITH A KNOW ADVERSE EFFECT RATE OF (B)(4).

    Additional Manufacturer Narrative · 0

    REPORT TYPE CHANGED FROM A 5 DAY TO AN INITIAL 30 DAY. THIS IS BASED ON TELEPHONE CONVERSATION BETWEEN FDA AND KELLY MOEYKENS (FHC) ON 3/5/2019.

    Description of Event or Problem · 1

    PROCEDURE - STAGED BI-LATERAL DBS PROCEDURE. THE FIRST SURGERY WAS PERFORMED (ONE SIDE OF A BI-LATERAL PROCEDURE). THE PATIENT WAS SENT HOME (PLANNED) AND WAS TO COME BACK AND DO THE SECOND SURGERY. FHC EMAILED TO CHECK ON WHEN THE SECOND SURGERY WAS GOING TO BE SCHEDULED AND THE HOSPITAL ADMINISTRATIVE PERSON SAID THE SECOND SURGERY WAS CANCELED BECAUSE THE PATIENT PASSED AWAY. THE SURGEON NOTED THAT THE SURGERY WENT GREAT, THE PATIENT WAS FINE AFTER SURGERY AND WENT HOME THE NEXT DAY AND HAD A DELAYED HEMORRHAGE AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178322 FHC MICROELECTRODE DEPTH ELECTRODE GZL FHC, INC, 44975Z

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 66-IT-AR4P - FHC INSERTION TUBE| 70-IT-AR5P - FHC INSERTION TUBE| BILATERAL DBS PLATFORM: SN (B)(4)| LP+: 31427 -| MTC: SN (B)(4)| STAR DRIVE: SN (B)(4) - FHC DRIVE SYSTEM