BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1842045 · Received September 21, 2010

    Report

    Report Number
    1226348-2010-00303
    Event Type
    Injury
    Date Received
    September 21, 2010
    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 Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE SURGEON WAS UNSUCCESSFUL IN THE ATTEMPT TO RE-PROGRAM THE DEVICE. AS A RESULT, THE VALVE WAS REMOVED FROM THE PT. THE VENTRICULAR CATHETER WAS NOT REMOVED AS IT ADHERED TO THE TISSUE. THE DR SUSPECTED THAT THE PT SUFFERED CEREBRAL MENINGITIS. NO OTHER VALVE WAS IMPLANTED BECAUSE THE SYMPTOM OF HYDROCEPHALUS HAD RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention