BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR W/SINGLE LUMEN PLASTIC BOLT (ADULT & PEDIATRIC)

    MDR report key: 6326085 · Received February 13, 2017

    Report

    Report Number
    1226348-2017-10106
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 25, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K) # OF SIMILAR PRODUCT CODE OF 826632: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. IT WAS LATER COMMUNICATED THAT THE DEVICE WAS DISCARDED. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION WAS PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE OR ADDITIONAL DEVICE IDENTIFYING INFORMATION IS PROVIDED, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, DURING THE MONITORING, AN ICP MICROSENSOR DIDN'T DETECT THE INTRACRANIAL PRESSURE. IT WAS REPLACED WITH A NEW ONE, NO ADVERSE CONSEQUENCES REPORTED. ACCORDING TO THE SURGEON THE NEW MICROSENSOR DESIGN RESULTS TO BE MORE RIGID AND WITH LOWER RESISTANCE TO THE NORMAL STRESSING FACTORS. AS REPORTED BY THE OUS AFFILIATE, THE EVENT CAUSED DELAYS OVER 30 MINUTES; THE MICROSENSOR WAS REMOVED AND MONITORING DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109711 ROHS MICROSENSOR W/SINGLE LUMEN PLASTIC BOLT (ADULT & PEDIATRIC) DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention