BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD

    MDR report key: 3140468 · Received May 31, 2013

    Report

    Report Number
    1226348-2013-17931
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT DURING THE VISUAL EXAMINATION OF THE DEVICE DEEP MARKS WERE NOTED IN THE SILICONE HOUSING AROUND THE END OF THE SIPHON GUARD, THE MARKS WERE NOTED ON OPPOSITE SIDES, WHICH MIGHT INDICATE THAT THE SIPHON GUARD WAS CLAMPED TOO TIGHT, THIS HOWEVER COULD NOT BE DETERMINED. IN ADDITION, A HOLE AND TEAR WAS ALSO FOUND IN THE NEEDLE CHAMBER. IT IS NOT POSSIBLE TO DETERMINE HOW THIS HAS HAPPENED. FURTHER EXAMINATION ALSO REVEALED THAT SINCE BIOLOGICAL DEBRIS WAS FOUND IN THE VALVE CASING IT WAS NOT POSSIBLE TO SEE THE CAM POSITION. THE VALVE COULD NOT BE IRRIGATED DUE TO THE DAMAGE OF THE SILICONE HOUSING. THE VALVE COULD NOT BE PROGRAM TESTED AS THE VALVE CAM MECHANISM WAS NOT VISIBLE DUE TO BIOLOGICAL DEBRIS. DUE TO THE DAMAGE IN THE SILICONE HOUSING, IT WAS NOT POSSIBLE TO PRESSURE TEST THE VALVE. 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE DEVICE WAS IMPLANTED AT 80MM H2O. THE PATIENT¿S VENTRICLES BECAME LARGE DUE TO A HEAD INJURY. THE PRESSURE WAS CHANGED FROM 80MM H2O TO 60MM H2O BUT THE PATIENT¿S CONDITION DID NOT CHANGE. THE PRESSURE WAS THEN CHANGED TO 40MM H2O AND THERE WAS STILL NO IMPROVEMENT. LASTLY, THE PRESSURE WAS CHANGED TO 30MMH2O WITH NO IMPROVEMENT IN THE PATIENT¿S CONDITION. AS A RESULT, THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242331 PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMHB4K

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention