BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE

    MDR report key: 1003858 · Received November 30, 2006

    Report

    Report Number
    1226348-2006-00356
    Event Type
    Injury
    Date Received
    November 30, 2006
    Date of Event
    November 1, 2006
    Manufacturer
    CODMAN & SHURLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REC'D THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTS THAT, DR EXPLANTED A PATIENTS VALVE BECAUSE THERE WAS VISABLE DEBRIS IN THE RESEVOIR AND THE CAM. REP REQUESTED REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 82-3072