BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING DRIVE SYSTEM NOTOR OPTION

    MDR report key: 1064036 · Received June 19, 2008

    Report

    Report Number
    3005677147-2008-00005
    Event Type
    Other
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FROM THE DISTRIBUTOR INDICATED A PROBLEM WITH THE MOTOR ACCESSORY. THE DRIVE AND MOTOR WERE REC'D FOR EVAL AND THE MOTOR SHOWED NO PROBLEMS. INSPECTION OF THE DRIVE SHOWED THAT THE BELT OF THE DRIVE HAD BROKEN AND THAT THE DRIVE CARRIAGE HAD BEEN FORCED TO ITS PHYSICAL LIMITS AND WAS STUCK IN PLACE. BASED ON THE RETURNED PRODS IT WAS CLEAR THAT THE PROD FAILURE OCCURRED AT THE DRIVE AND NOT WITH THE MOTOR ACCESSORY. REVIEW OF REPAIR AND MAINTENANCE DOCUMENTS INDICATE THIS DRIVE HAD NOT BEEN IN FOR ANY ROUTINE SVC RO ANY REPAIR OVER ITS LIFETIME. ROUTINE SVC IS NOTED IN THE DFU AND WOULD HAVE RESULTED IN THE REPLACEMENT OF THE BELT AS WELL AS AN EVAL OF THE PROD'S OVERALL PERFORMANCE. RESULTS: USE AND FUNCTION OF MOTOR WAS CORRECT; MAINTENANCE OF THE DRIVE WITH WHICH IT WAS USED WAS THE PROBLEM. THE DRIVE NOT THE MOTOR. CONCLUSIONS APPLY TO THE DRIVE, NOT TO THE MOTOR. THE MOTOR FUNCTIONED AS IT SHOULD HAVE; IT WAS THE LACK OF MAINTENANCE ON THE DRIVE THAT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DEEP BRAIN STIMULATION SURGERY WAS ABORTED AND NEXT SURGERY WAS CANCELLED DUE TO DEVICE FAILURE DESCRIBED AS "MOTOR STALL". NO FURTHER PT IMPACTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING DRIVE SYSTEM NOTOR OPTION HAW HAW FHC, INC. 66-DA-ME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL # 9033G0601| MEDTRONIC MICROTARGETING DRIVE