BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 2190977 · Received July 29, 2011

    Report

    Report Number
    1226348-2011-00287
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 24, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE APPARENT ROOT CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER WAS DUE TO BIOLOGICAL DEBRIS. BIOLOGICAL DEBRIS CAUSED THE DEVICE TO FAIL THE PROGRAMMING TEST. DEBRIS FOUND THROUGHOUT THE DEVICE COULD POTENTIALLY CAUSE THE PROBLEM OUTLINED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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 DEVICE WAS EXPLANTED AS A RESULT OF OVER DRAINAGE. IT WAS NOTED THAT THE VALVE WAS USED IN CONJUNCTION WITH ANOTHER DEVICE FROM ANOTHER MEDICAL DEVICE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA CMBB2M

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention