BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDELINE 4000 LP+

    MDR report key: 3530413 · Received November 20, 2013

    Report

    Report Number
    3005677147-2013-00004
    Event Type
    Other
    Date Received
    November 20, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 30, 2013
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K071364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS REC'D FROM DR. (B)(6), NEUROPHYSIOLOGIST IN CHARGE OF DOCUMENTING THE RECORDINGS DURING THE CASE, ON (B)(6) 2013. THE PT HAS RECOVERED WELL. ABNORMAL MOVEMENTS HAVE INCREASED PERHAPS DUE TO STRESSFUL ARTIFACTS CONTINUING FROM THE CASE. BOTH DR. NEUROSURGEON AND DR. (B)(6), NEUROPHYSIOLOGIST, NOTE THAT THERE IS NO INDICATION THAT FHC'S EQUIPMENT OR CONSUMABLES HAD ANYTHING TO DO WITH THE PT CONDITION DURING OR AFTER THE CASE. THE PT HAD NO HISTORY OF CARDIAC OR RESPIRATORY COMPLICATIONS PRIOR TO THE SURGERY SO THAT THE EVENTS DURING THE SURGERY WERE UNEXPECTED.

    Description of Event or Problem · 1

    GREENVILLE NEUROMODULATION SERVICES, INC., PROCEDURAL SUPPORT TECHNICIAN REPORTED THAT ON (B)(6) 2013, THERE WAS A, PLANNED, BILATERAL SURGERY WITH DR. (B)(6). THE PT HAD DYSTONIA. DR. (B)(6) STARTED ON THE LEFT SIDE. DR. (B)(6) PERFORMED THREE PASSES ON THE LEFT SIDE. FIRST, THE CENTER TRACK, THEN POSTERIOR, THEN ANTERIOR. UPON COMPLETION OF MICROELECTRODE RECORDING ON THE LEFT SIDE, COMPLICATIONS AROSE WITH THE PT AND THE SURGERY HAD TO BE CANCELED BEFORE THE LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604319 GUIDELINE 4000 LP+ LP+ GZL FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK