BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6680055 · Received June 30, 2017

    Report

    Report Number
    1226348-2017-10456
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    March 8, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES WHEN THE DEVICE WAS RELEASED TO STOCK. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT WILL BE CLOSED AT THIS TIME AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR STOPPED WORKING AFTER A PATIENT WAS X-RAYED. ALTERNATE MONITOR AND CABLE USED WITH NO IMPROVEMENT. ISSUE ISOLATED TO SENSOR. DEVICE WAS DISCARDED. IT WAS REPORTED THAT THE ISSUE RESULTED IN LONG OPERATION TIME, MONITORING OF ICP WAS MISSING FOR ABOUT THREE HOURS. A NEW MICROSENSOR WAS PLACED. IT WAS REPORTED THAT THE PATIENT DEVELOPED PARENCHYMAL BLEEDING, WHICH COULD NOT BE RULED OUT AS RELATED TO THE RENEWED MICROSENSOR INSERTION TESTS - WHICH HAD NOT BEEN REQUIRED IF THE FIRST SENSOR HAD CEASED TO FUNCTION / BROKE RELATED TO STATIC ELECTRICITY. THE PATIENT HAS SUFFERED A SERIOUS HEALTH CARE RELATED TO THE RENEWED MICROSENSOR INSERTION. IT WAS ALSO REPORTED THAT THE EVENT LED TO A DELAY IN SURGERY OF GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462703 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. 111974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention