BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

    MDR report key: 3760365 · Received April 20, 2014

    Report

    Report Number
    1226348-2014-11406
    Event Type
    Injury
    Date Received
    April 20, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    REP REPORTED VIA EMAIL THAT THE PROCEDURE WENT SMOOTHLY AND THE VALVE WAS SET TO 4. THE NEXT MORNING, THE PATIENT DEVELOPED SUB-DURALS DUE TO OVER DRAINAGE. DR. (B)(6) CAME IN AND EXPERIENCED A POST OP PATIENT OF 18 HOURS WHO, AS EXPECTED, HAD EDEMA AT THE OP SITE. THE SWELLING WAS NOTHING DR. (B)(6) WOULD SAY IS EXCESSIVE OR UNUSUAL. HOWEVER, IT WAS TOO MUCH FOR OUR PROGRAMMING TOOLS TO HANDLE. HE COULD NOT CONFIDENTLY LOCATE THE VALVE AND SUBSEQUENTLY COULD NOT GET THE INDICATOR TO PROVIDE ACCURATE INFO. NEEDLESS TO SAY THE PATIENT WAS X-RAYED TO DETERMINE SETTING AND THEN AGAIN AFTER REPROGRAMMING BECAUSE THE INDICATOR WOULD NOT WORK. (B)(4). PLEASE REFER TO COMPLAINT COD-431-2012. A FOLLOW-UP IS BEING GENERATED BECAUSE B1 IN THE MEDWATCH NEEDS TO BE POPULATED TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239201 SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention