BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING PLATFORM

    MDR report key: 8946803 · Received August 29, 2019

    Report

    Report Number
    3002250546-2019-00003
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    April 12, 2019
    Report Date
    August 29, 2019
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    UDI-DI
    00873263005941
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON "05/97/19" BUT DUE TO A TECHNICAL ERROR, IT DID NOT UPLOAD.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED ON (B)(6) 2019 THAT HE ABORTED HIS DBS IMPLANTATION PROCEDURE BECAUSE THE PATIENT WAS HAVING DIFFICULTY FINDING WORDS. THIS PROCEDURE INVOLVED PLANNING WITH FHC'S WAYPOINT NAVIGATOR AND USAGE OF MICROTARGETING PLATFORM. ELECTRODES, CANNULAE AND DRIVE WERE NOT FHC PRODUCTS. ON FOLLOW UP ON (B)(6) 2019, PHYSICIAN INFORMED THAT A POSTOPERATIVE CT SCAN SHOWED AN INTRACRANIAL HEMORRHAGE, AND THE PATIENT WILL NO LONGER BE A CANDIDATE FOR THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739115 MICROTARGETING PLATFORM STEREOTAXIC INSTRUMENT HAW FHC, INC, 00873263005941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other