BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3772313 · Received April 25, 2014

    Report

    Report Number
    1226348-2014-11416
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    February 20, 2012
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALREADY PROVIDED REFERENCE # CONTINUED TO POP ON THE SCREEN WANTING TO ACCEPT OR NOT ACCEPT AS IF A BREAK IN THE CIRCUIT WAS OCCURING. DISCARDED SENSOR...REPLACED WITH NEW SENSOR. SURGERY WAS DELAYED MORE THAN 30 MINUTES. CUSTOMER COMPLAINING THAT RECENTLY ORDERED ICP CABLES CONTINUE TO STOP WORKING, SHOWING AN ERROR MESSAGE CANNOT DETECT TRANSDUCER. CABLE APPEARS TO BE IN GOOD CONDITION WITH NO SIGN OF EXTERNAL DAMAGE. CUSTOMER IS ASKING CODMAN TO REPLACE. (B)(4) REP CONFIRMED THAT THE DEVICE WAS IMPLANTED FOR A FEW MINUTES, NOT SEWN DOWN, BUT REPLACED DUE TO THE DIFFICULTY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251950 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CNDB8T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention