BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING DRIVE SYSTEM

    MDR report key: 1016384 · Received March 12, 2008

    Report

    Report Number
    3005677147-2008-00001
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO REGARDING THIS EVENT WAS INITIALLY RECEIVED FROM THE DISTRIBUTOR'S REPRESENTATIVE. FHC EVALUATED THE MICROTARGETING PLATFORM FOR POSSIBLE TARGETING ERROR AND CONCLUDED THAT THE DEVICE WAS MANUFACTURED AND PERFORMED ACCORDING TO SPECIFICATIONS. FURTHER INVESTIGATION (IE, PHONE CONVERSATION WITH NEUROSURGEON) INTO THE INCIDENT CONCLUDED THAT THERE WAS NO FAILURE TO ANY FHC PRODUCT IN THIS SURGERY, WHICH INCLUDED THE MICROTARGETING DRIVE AND ENCODER, MICROTARGETING ELECTRODES AND THE AXON GUIDELINE SYSTEM 3000. IN ADDITION, ALL FHC PRODUCTS NOTED HERE WERE USED IN THE SUBSEQUENT SURGERY AND FUNCTIONED PROPERLY. NO PT INJURY OR HARM WAS NOTED DURING THIS CASE OTHER THAN A SECOND SURGERY TO REPOSITION THE DBS LEAD. NOTE: THE DBS LEAD IS NOT AN FHC PRODUCT AND THIS REPORT IS BEING FILED TO DOCUMENT THE USE OF THE FHC PRODUCTS DURING THE EVENT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR'S REPRESENTATIVE REPORTED THAT FOLLOWING BILATERAL LEAD PLACEMENT (DATE WAS NOT PROVIDED); LEAD MIGRATION HAD BEEN SUSPECTED BY THE SURGEON. NO PT SYMPTOMS WERE REPORTED. THE PT UNDERWENT A SECOND SURGERY (DATE UNK), WHERE THE LEAD WAS FOUND SECURE, BUT HAD BEEN PLACED IN AN AREA ESTIMATED TO BE 1.5 TO 2 CM HIGHER THAN THE ORIGINAL TARGET LOCATION. THERE HAD BEEN NO MALFUNCTION OF THE LEAD; THE DEPTH CAP HAD BEEN PROPERLY INSTALLED AND THE LEAD HAD BEEN MEASURED PRIOR TO PLACEMENT. DURING THE REVISION PROCEDURE, THE LEAD WAS REPOSITIONED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING DRIVE SYSTEM STEREOTACTIC POSITIONER HAW FHC, INC. 66-MP-BT-NNN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MICROTARGETING DRIVE WITH ENCODER OPTION| MICROTARGETING ELECTRODES| AXON GUIDELINE SYSTEM 3000