BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING PLATFORM

    MDR report key: 1914458 · Received November 23, 2010

    Report

    Report Number
    3005677147-2010-00010
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INCORRECTLY LABELED AT SHIPMENT. WHILE THE PLATFORM WAS MEASURED CORRECTLY, THE TEXT ON THE LEG WAS NOT CORRECT. BECAUSE THE TEXT ON THE LEG CAUSED THE SURGEON TO PLACE THE IMPLANTABLE LEAD TOO HIGH, THERE WAS NO RISK TO PT HEALTH BUT A RESCHEDULED SURGERY WILL BE NECESSARY TO CORRECT THE PLACEMENT.

    Description of Event or Problem · 1

    DISTRIBUTION REPORTED TO FHC THAT A SURGEON WAS NOT GETTING THE RESULTS HE EXPECTED AFTER HIS (B)(6) 2010 SURGERY USING FHC'S PT-CUSTOMIZED SURGICAL FIXTURE (PLATFORM). THE POST OPERATIVE CT SCAN INDICATED THE IMPLANTED LEADS WERE TOO HIGH. AN FHC RESEARCH AND DEVELOPMENT ENGINEER CHECKED THE SOFTWARE FILE USED TO CREATE THE PLATFORM BUILD AND REALIZED THAT AN ERROR HAD BEEN MADE IN THE LABELING OF THE LEGS ON THE PLATFORM. THE SURGERY WILL NEED TO BE RESCHEDULED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING PLATFORM PLATFORM HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention WAYPOINT STEREOTACTIC SYSTEM| MICROTARGETING DRIVE SYSTEM