BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4791380 · Received May 22, 2015

    Report

    Report Number
    1226348-2015-10286
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 22, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    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. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. THE LOT HISTORY RECORD WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK ON THE JUNE 03RD, 2004. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER MENTIONED THAT THEY WANT TO SEND ONE IN FOR INVESTIGATION. CURRENTLY UNKNOWN WHAT HAS HAPPENED. BUT THE RESPONSIBLE SALES REP IS TRYING TO GET MORE INFORMATION FROM THE CUSTOMER EVENT DATE UNKNOWN. ON (B)(6) 2015, SHUNT REVISION DUE TO THAT IT IS IMPOSSIBLE TO ADJUST WITH THE VPV. THEY SUSPECTS THAT IT IS DUE TO PROTEIN OCCLUSION(?) ART: 823113, LOT: PBA778, ORG IMPLANT DATE: (B)(6) 2005, EXPLANT: (B)(6) 2015, REPLACED WITH: REPLACED W 823100 OR 823111, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334247 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. 1191214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention