BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING GUIDELIEN 4000 LP+

    MDR report key: 2561511 · Received April 30, 2012

    Report

    Report Number
    3005677147-2012-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    March 21, 2012
    Report Date
    April 2, 2012
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K071364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVAL OF THE LP+ SYSTEM, THE FHC TECHNICAL SUPPORT INDIVIDUAL COULD NOT REPRODUCE THE ISSUE. NONETHELESS THE PREAMP WAS REPLACED AND THE SYSTEM WAS FOUND TO BE STABLE THROUGHOUT THE SUBSEQUENT SURGERY. FHC PERFORMED AN INTERNAL RISK ASSESSMENT AND DETERMINED THAT THERE WAS NO SIGNIFICANT RISK TO THE PT, AS THE SYSTEM PERFORMED AS REQUIRED.

    Description of Event or Problem · 1

    USER REPORTED TO FHC'S EUROPEAN UNION AUTHORIZED REP ABOUT AN ISSUE WITH THE MICRO TARGETING GUIDELINE 4000 LP+. DURING AN ONGOING SURGERY WHILE STIMULATING ON CHANNEL 1 WITH THE LP+ SYSTEM, THE PULSE DURATION CHANGED TO 1000 MICROSECONDS FROM 70 MICROSECONDS WHICH THE SYSTEM WAS ORIGINALLY SET AT, WHICH LED TO A PAINFUL SENSATION TO THE PT. THE STIMULATION AND PAIN STOPPED AS SOON AS THE STIMULATION BUTTON WAS RELEASED. THE SYSTEM THEN FROZE AND COULD ONLY BE TERMINATED USING WINDOWS TASK MGR. THE SURGERY WAS THEN CONTINUED USING ANOTHER SYSTEM AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO EVIDENCE THAT THE PT WAS HARMED BY THE LP+ SYSTEM DURING OR AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING GUIDELIEN 4000 LP+ LP+ GZL FHC, INC. MT-LPP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other