BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 1881287 · Received October 6, 2010

    Report

    Report Number
    1226348-2010-00328
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. A VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED FROM THE BASE PLATE, AND THE SPRING WAS SITTING UNDER THE STATOR AND THE CAM MECHANISM, BECAUSE OF THIS THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. NO OTHER DAMAGES AND/OR EVIDENCE OF INAPPROPRIATE USE WERE OBSERVED. THE CAUSE(S) OF THE DISLODGEMENT COULD NOT BE DETERMINED. HOWEVER, THIS VALVE WAS MFG PRIOR TO ENHANCEMENTS INTRODUCED TO THE STATOR STAMPING TOOL DURING 2004/2005 THAT WAS DESIGNED TO MINIMIZE THIS TYPE OF DISLODGEMENT. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECS WHEN RELEASED TO STOCK. 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

    AFFILIATE REPORTED THAT A ROUTINE MRI WAS CONDUCTED AND AFTERWARDS THE VALVE WAS MISALIGNED. IT WAS NOT POSSIBLE TO ADJUST THE VALVE TO A NEW PRESSURE. AFTER THAT ATTEMPT THEY MADE AN X-RAY WHICH SHOWED THAT THE STATOR WAS DISLODGED. THEREFORE THEY DECIDED TO EXPLANT THE VALVE AND REPLACE IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA 1144164

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR