BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET CORTICAL STIMULATOR

    MDR report key: 5067052 · Received September 10, 2015

    Report

    Report Number
    3010611950-2015-00017
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    NATUS NEUROLOGY, INCORPORATED
    Product Code
    GYC
    PMA / PMN Number
    K072964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    1) THIS IS A RE-FILING OF REPORT 3008289288-2014-00004 WITH A NEW REPORT NUMBER. THE REPORT WAS EDITED ON (B)(6) 2015 TO REVISE THE FACILITY REGISTRATION NUMBER FROM (B)(4). THE CURRENT FACILITY REGISTRATION NUMBER CHANGED IN MAY 2014 WHEN NATUS NEUROLOGY INC. MOVED TO ITS CURRENT LOCATION AT (B)(4). PATIENT INFORMATION WAS NOT PROVIDED, PATIENT AGE AND WEIGHT ARE THEREFORE DEFAULTED TO "0". DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. REGISTERED INTERNALLY AS A COMPLAINT ((B)(4)) FOR FURTHER INVESTIGATION BY MANUFACTURER. THE INTERNAL INVESTIGATION COULD NOT REPRODUCE THE PROBLEM CONDITION REPORTED NOR DID THE COMPLAINANT RESPOND TO FURTHER INFORMATION REQUESTS. SUBSEQUENTLY, NO OTHER FOLLOW UP ACTIONS WERE TAKEN.

    Description of Event or Problem · 1

    WHILE PERFORMING AN EEG EXAM USING A NICOLET CORTICAL STIMULATOR, THE HEALTHCARE PROFESSIONAL USING THE STIMULATOR NOTED THAT THE EQUIPMENT REPORTED AN OUTPUT STIMULATION LEVEL OF "0" WHEN STIMULATION WAS APPLIED EVEN THOUGH THE EQUIPMENT WAS SET TO DELIVER STIMULATION. A SMALL LEVEL OF STIMULATION WAS ALSO NOTED AS AN EEG ARTIFACT ALTHOUGH THE LEVEL APPEARED LOW WHEN COMPARED TO OTHER EQUIPMENT LATER USED (ONCE NOTICED, THE HEALTHCARE PROFESSIONAL SWITCHED TO A DIFFERENT STIMULATION METHOD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600240 NICOLET CORTICAL STIMULATOR CORTICAL STIMULATOR GYC NATUS NEUROLOGY, INCORPORATED 982A0558

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other