BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEKTOR

    MDR report key: 881395 · Received June 16, 2007

    Report

    Report Number
    9612330-2007-00002
    Event Type
    Other
    Date Received
    June 16, 2007
    Date of Event
    May 31, 2007
    Manufacturer
    EXCEL-TECH LTD.
    Product Code
    GWF
    PMA / PMN Number
    K040358
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED FOR EVALUATION HAD WET MARKS INSIDE THE STIM BOX. IT IS CONCLUDED THAT THIS INCIDENT WAS CAUSED BY LIQUID INGRESS INSIDE THE PROTEKTOR STIM BOX. AND THE FLUCTUATING OUTPUT FROM CHANNEL "C" WAS CAUSED BY LIQUID INGRESS. KEEPING THE UNIT DRY WOULD HAVE PREVENTED THE MALFUNCTION OF THE DEVICE. REFERENCE: USER MANUAL PART NUMBER - 104342C. GENERAL WARNING AND CAUTIONS: "THE PROTEKTOR HEADBOXES CARRY ORDINARY CLASSIFICATION FOR THE LEVEL OF PROTECTION AGAINST INGRESS OF LIQUIDS (IPXO). THEY ARE NOT DRIP OR SPLASH PROOF. AVOID LETTING LIQUID SEEP INTO ANY OF THE INTERNAL ELECTRONICS OF THE SYSTEM."

    Description of Event or Problem · 1

    THE PATIENT RECEIVED LESION AT THE STIMULATING ELECTRODE STE ON HIS LEFT WRIST WHILE UNDERGOING SPINAL SURGERY WITH INTRAOPERATIVE SOMATOSENSORY EVOKED POTENTIAL MONITORING A SMALL CIRCULAR MARK WAS NOTED ON LEFT WRIST DIRECTLY UNDER THE STIMULATING ELECTRODE. THE RIGHT WRIST WAS UNAFFECTED. LEFT WRIST WAS TREATED TOPICALLY WITH OINTMENT AND COVERED WITH BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEKTOR GWF EXCEL-TECH LTD. PROTEKTOR STIM BOX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other