BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 5647743 · Received May 11, 2016

    Report

    Report Number
    1226348-2016-10361
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 24, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE 82-3110 HAD IMPLANTED ON (B)(6) 2014 AT (B)(6) HOSPITAL, THEN WAS TAKEN OUT ON (B)(6) 2015 AT (B)(6) HOSPITAL BECAUSE OF REVISION OPERATION. BEFORE THE REVISION SURGERY, THE PROBLEM WAS THAT 82-3110 DID NOT OPERATE WELL BASED ON THE SURGEON'S COMMENT. FOR THIS REASON, THE SURGEON WHO PERFORMED THE REVISION SURGERY DOUBTED THAT 82-3110 IS A DEFECTIVE PRODUCT AND HE REQUESTED (B)(4) TO PROVE THE 82-3110 WAS NOT A DEFECTIVE PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302827 HAKIM PROGRAMMABLE VALVE W/PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention