BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

    MDR report key: 3760240 · Received April 19, 2014

    Report

    Report Number
    1226348-2014-11392
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE IN B1 CLASSIFICATION. IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM.

    Description of Event or Problem · 1

    REP REPORTED THAT THE SURGEON WAS UNABLE TO VISUALIZE ANY MARKERS ON XRAY, UNABLE TO DETERMINE ORIENTATION AND UNABLE TO ACCURATELY DETERMINE SETTING VIA XRAY. SURGEON DECIDED TO XRAY THE PATIENT AT PATIENT FOLLOW UP. NO ADVERSE CONSEQUENCES TO THE PATIENT. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE IN B1 CLASSIFICATION. IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239087 SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CMMBCY

    Patients

    Seq Age Sex Outcome Treatment
    1