BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6775432 · Received August 8, 2017

    Report

    Report Number
    1226348-2017-10557
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 12, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, AFTER BEING IMPLANTED FOR 3 WEEKS A MICROSENSOR AND DIRECTLINK TOOK REPEATED TRIES AND SEVERAL HOURS TO ZERO THE SENSOR AFTER BEING UNCOUPLED FOR AN MRI PROCEDURE. NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555483 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1