BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 2120261 · Received June 7, 2011

    Report

    Report Number
    1226348-2011-00211
    Event Type
    Injury
    Date Received
    June 7, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC, MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MFG SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. 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 THE INCISION WAS NOT HEALING WELL AND AN X-RAY INDICATED THAT AIR WAS FOUND AROUND THE CATHETER, INSIDE THE RESERVOIR AND THE VENTRICLE OF THE BRAIN. AS A RESULT THE DEVICE WAS REVISED. THE SURGEON DID NOT THINK THAT THERE WAS RELATION BETWEEN IMPLANT REMOVAL AND THE PRODUCT QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC, MEDOS S.A. NA CLCDFP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention