BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE, RT ANGLE

    MDR report key: 4243611 · Received November 11, 2014

    Report

    Report Number
    1226348-2014-12097
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    November 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: THE PATIENT¿S CHPV HAS CHANGED IT¿S SETTING NOW ON TWO SEPARATE OCCASIONS, FROM 120 DOWN TO 80/90. AFTER IT HAPPENED, THE FIRST TIME, ADJUSTING DOWN TO 80/90, THE VALVE WAS ADJUSTED BACK TO 120 BY A REGISTRAR & VERIFIED ON X RAY. THIS HAS NOW HAPPENED FOR A SECOND TIME & THEY ARE CONSIDERING EXPLANTING. PATIENT IS WAITING FOR A REMOVAL & CHANGE OF VALVE. THE PATIENT HAS SUFFERED WITH HEADACHES & HAS REPORTED FEELING UNWELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727070 HAKIM PROGRAMMABLE VALVE, RT ANGLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CKFCBZ

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention