BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO TARGETNING ELECTRODE - DZAP

    MDR report key: 5168084 · Received October 16, 2015

    Report

    Report Number
    3005677147-2015-00003
    Event Type
    Injury
    Date Received
    October 16, 2015
    Date of Event
    September 8, 2015
    Report Date
    October 14, 2015
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY DISCARDED DEVICE. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED TO BE IMPLANTED FOR A LEFT VIM DBS ELECTRODE. DURING MICROELECTRODE RECORDING, THE PATIENT EXPERIENCED BRADYCARDIA AND BECAME DIFFICULT TO AROUSE. THE PROCEDURE WAS ABORTED. THE SURGEON SUSPECTED THE PATIENT SUFFERED A HEMORRHAGE. FHC MICRO TARGETING DZAP ELECTRODES WERE USED IN THE PROCEDURE. THE PATIENT HAD AN INFARCT ALONG THE TRACT DURING THE SECOND MER PASS. THE PATIENT MADE GOOD GAINS POST-OP AND IS IN THE INPATIENT REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687889 MICRO TARGETNING ELECTRODE - DZAP GZL FHC, INC. 34685Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening