BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

    MDR report key: 3760364 · Received April 20, 2014

    Report

    Report Number
    1226348-2014-11405
    Event Type
    Injury
    Date Received
    April 20, 2014
    Date of Event
    March 12, 2012
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN A PHONE CONVERSATION THE CUSTOMER REPORTED THAT: "PATIENT HAD THE CERTAS VALVE IMPLANTED ON (B)(6) 2012. AFTER APPROXIMATELY ONE MONTH, IT WAS VERIFIED THAT THE VALVE WAS OVER-DRAINING, AND HAD TO BE EXPLANTED." ADDITIONAL INFORMATION CALLED IN ON (B)(6) 2012 BY THE PATIENT'S NIECE EXPLAINED THAT DR. (B)(6) CALLED TO REPORT THAT ON (B)(6) 2012, HER UNCLE'S CERTAS VALVE (IMPLANTED ON (B)(6)) INDICATED THAT THE FLOW AT CAT SCAN WAS TOO HIGH. A SMALL SUBDURAL COLLECTION WAS FORMING. THE VALVE WAS ADJUSTED TO A RATE OF 5 ON (B)(6) AND TO 8 ON (B)(6). THE FLOW COLLECTION WORSENED, THEREFORE; SURGERY WAS PERFORMED TO TIE OFF CATHETER. THE VALVE WAS REMOVED ON (B)(6) 2012. BILATERAL BURR HOLES FOR BILATERAL SUBDURAL HEMATOMA EVACUATION WAS PERFORMED DUE TO DETERIORATING NEUROLOGICAL STATUS. PATIENT CONDITION IS STABLE PATIENT HAS NO VALVE AND IS HOME. PER (B)(6) THE REP (B)(4) PICKED UP THE VALVE ON (B)(4). NOTE: THE REP WAS CONTACTED AND INDICATED THAT HE ALREADY CALLED IN THIS COMPLAINT AND THAT (B)(4) WAS ASSIGNED. THEREFORE; THIS COMPLAINT WAS REJECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239194 SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention