BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMUPLEX

    MDR report key: 2163777 · Received July 1, 2011

    Report

    Report Number
    9610825-2011-00075
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BXN
    PMA / PMN Number
    K052313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    STIMUPLEX HNS 12 NERVE STIMULATOR WAS RETURNED TO BBRAUN (B)(4) AND SENT TO THE MANUFACTURER FOR EVAL (B)(4) 2011. A FOLLOW UP WITH THE FACILITY WAS CONDUCTED ON (B)(4) 2011. (B)(6), BIO-MED OF USER FACILITY, STATED THAT THERE WAS NO PT INJURY. HE ALSO STATED THAT THE DIAL WAS TURNED UP TO ITS HIGHEST VOLTAGE (5 VOLTS) WHEN ADMINISTERED TO THE PT. HE NOTED THIS WILL GENERALLY CAUSE DISCOMFORT WHEN DOING SO. HE ALSO STATED THAT GENERAL PRACTICE WITH THIS DEVICE IS TO START AT 1 TO 1.5 VOLTAGES AND SLOWLY TURN IT UP TO 5 VOLTAGES. WHILE IT DOES NOT APPEAR AT THIS TIME THAT THERE WAS A DEVICE MALFUNCTION, THE MANUFACTURER'S INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. SHOULD THE MANUFACTURER'S INVESTIGATION IDENTIFY ANY ISSUES WITH THE INVOLVED DEVICE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    STIMUPLEX HNS 12 NERVE STIMULATOR. AS REPORTED BY USER FACILITY: HNS12 UNIT, (B)(4) ON 2 OCCASIONS, "SHOCKED PT," LAST EPISODE OCCURRED ON (B)(6) 2011. GROUND PAD IN PLACE ATTACHED TO RED END OF CABLE, NEEDLE PLACED IN BLACK END OF CABLE, WHEN UNIT TURNED ON, PT EXPERIENCED A "SHOCK." NO FURTHER DETAILS AVAILABLE AS TO LOCATION, INTENSITY OF SHOCK. INFO FROM (B)(6). (B)(6) STATES CABLE IS IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMUPLEX STIMUPLEX HNS 12 NERVE STIMULATOR BXN B. BRAUN MELSUNGEN AG HNS 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other