BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 6685691 · Received July 5, 2017

    Report

    Report Number
    1226348-2017-10471
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    December 22, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. NUMEROUS ATTEMPTS WERE MADE TO RECOVER THE DEVICE, WITH NO SUCCESS. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. A SEARCH FOR RELATIVE COMPLAINT FOR THE SAME ISSUE WITH THE SAME PRODUCT CODE AND LOT NUMBER FOR THE LAST YEAR REVEALED THAT THIS IS THE ONLY ISSUE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113 WITH LOT CTDBMY, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 5TH MAY. 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.

    Description of Event or Problem · 1

    BLOCKAGE IN SHUNT. THERE IS NO REPORT OF INJURY FOR THE PATIENT. THE TIMING OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469069 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTDBMY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention