BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM

    MDR report key: 14582420 · Received June 2, 2022

    Report

    Report Number
    3002250546-2022-00001
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 27, 2022
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K183123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM WAS RETURNED TO FHC FOR EVALUATION. EVALUATION COULD NOT DETERMINE THE CAUSE OF THE ISSUE IN THE FIELD.

    Description of Event or Problem · 0

    ON (B)(6) 2022 DURING A UNILATERAL DBS CASE IT WAS REPORTED THAT THE PATIENT EXPERIENCED VERY STRONG CONTRACTIONS ON HIS HAND WHEN MACRO-STIMULATING WITH CONSTANT CURRENT 0.25 MA ON CENTRAL AND LATERAL TRACKS. STIMULATION WAS IMMEDIATELY TURNED OFF. STIMULATION WAS TRIED AGAIN AND THE SYSTEM SHOWED A MALFUNCTION MESSAGE AND SHUT DOWN. IN THAT MOMENT, THE PATIENT FELT A STRONG STIMULATION AGAIN. THE ELECTRODE IMPEDANCE WAS 900 AND THE RECORDINGS ON BOTH TRACKS WERE GOOD. THE OUTPUT VOLTAGE WAS NOT NOTED. PHYSICIAN REQUESTED TO DISCONNECT THE ELECTRODE CABLES AND IMPLANTED THE DBS LEAD TO MACRO-STIMULATE WITH IT. WHEN STIMULATING WITH THE LEAD, NO ADVERSE EFFECTS WERE REPORTED. PATIENT RECOVERED HIS ARM MOVEMENT ONCE THE STIMULATION WITH THE GL5 STOPPED. SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT HAD HIS FIRST LEAD IMPLANTED A YEAR AGO. THIS WAS THE SECOND SIDE (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171448 MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM GUIDELINE 5 GZL FHC, INC. GUIDELINE 4000 5.0 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization