BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 6453900 · Received April 3, 2017

    Report

    Report Number
    1226348-2017-10227
    Event Type
    Injury
    Date Received
    April 3, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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 REP, SURGEON HAS USED 82-3113 FOR YEARS AND HAS RECENTLY EXPERIENCED AN INCREASE IN SUBDURALS. SHE DID NOT HAVE SPECIFIC CASE DATES/PATIENT INFORMATION OTHER THAN SAYING THAT IT "HAPPENED WITH 3-4 PATIENTS BACK IN THE FALL" AND THAT THE PATIENTS WERE SYMPTOMATIC RIGHT AWAY. MOVING FORWARD, SHE PLANS TO START PATIENTS AT A HIGHER SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235051 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention