BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-SHUNT KIT, BURR HOLE VALVE, 16MM, MEDIUM, STANDARD 90CM

    MDR report key: 3981783 · Received August 5, 2014

    Report

    Report Number
    2021898-2014-00287
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE NOTES THAT IT MAY BE NECESSARY TO DEPRESS THE VALVE DOME MORE THAN ONCE TO INITIATE FLOW, ESPECIALLY IF THE VENTRICULAR CATHETER HAS BEEN ATTACHED PRIOR TO PATENCY TESTING. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE NOTES THAT IT MAY BE NECESSARY TO DEPRESS THE VALVE DOME MORE THAN ONCE TO INITIATE FLOW, ESPECIALLY IF THE VENTRICULAR CATHETER HAS BEEN ATTACHED PRIOR TO PATENCY TESTING. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. IT WAS LATER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS DOING WELL. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THAT PRIOR TO BEING IMPLANTED IN THE PATIENT THE VALVE COMPONENT OF THE SHUNT DID NOT REFILL WITH FLUID DESPITE SEVERAL ATTEMPTS TO CHECK ITS PATENCY AS ADVISED IN THE PRODUCT LABELING. THE REPORT STATES THAT THE PATENCY OF THE VENTRICULAR CATHETER WAS NOTED BECAUSE CSF WAS OBSERVED FLOWING OUT OF THE CATHETER COMPONENT, AND THAT THE VALVE WAS NONETHELESS IMPLANTED. ACCORDING TO THE REPORT, THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457698 CSF-SHUNT KIT, BURR HOLE VALVE, 16MM, MEDIUM, STANDARD 90CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D51863

    Patients

    Seq Age Sex Outcome Treatment
    1