BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENT RES TR RICKHAM LG BA

    MDR report key: 4775670 · Received May 15, 2015

    Report

    Report Number
    1226348-2015-10289
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 8, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. 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. DEVICE DISCARDED BY USER FACILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THIS CASE, (B)(6), IS A REPORT FROM (B)(6), REFERRING TO A (B)(6) YEAR-OLD FEMALE SUBJECT (ID # (B)(6)). AN INVESTIGATOR REPORTED THIS CASE FROM THE (B)(6) STUDY, A PHASE 1/2 OPEN-LABEL DOSE-ESCALATION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF INTRACEREBROVENTRICULAR BMN 190 IN PATIENTS WITH NEURONAL CEROID LIPOFUSCINOSIS TYPE 2 (NCL-2) DISEASE. ON (B)(6) 2014, A RICKHAM VENTRICULOSTOMY SET, MODEL 82-1623 MANUFACTURED BY CODMAN & SHURTLEFF, (510K NUMBER K102961). WAS IMPLANTED. THE DEVICE LOT NUMBER WAS CPBB2G, UDI NUMBER 171231CPBB2G AND SERIAL NUMBER WAS REPORTED AS UNKNOWN. ON (B)(6) 2015, PRIOR TO START INFUSION CEREBROSPINAL (CSF) FLUID WAS DRAWN PER PROTOCOL. UPON VISUAL INSPECTION, CSF WAS NOTED TO BE VERY CLOUDY AND INFECTION WAS SUSPECTED. THE SUBJECT HAD NO FEVER PRIOR TO THE INFUSION. AT 12:00, BMN 190 INFUSION WAS STARTED. AT 13:30, THE TEST RESULTS OF CSF WERE RECEIVED: CSF WHITE BLOOD CELL (WBC) WAS 707 AND CSF PROTEIN WAS 73.6 (UNITS NOT REPORTED), THE INFUSION WAS INTERRUPTED AND TREATMENT WITH INTRAVENOUS CEFTRIAXONE BID, WAS INITIATED...ON (B)(6) 2015, CT SCAN WITH CONTRAST WAS NORMAL...ON (B)(6) 2015, THE CEFTRIAXONE WAS STOPPED...ON (B)(6) 2015, CSF SHOWED AN IMPROVEMENT IN CELLULARITY WITH DECREASE OF WHITE BLOOD CELLS TO 182/M3. ON THE SAME DATE, LUMBAR PUNCTURE WAS NORMAL. ON (B)(6) 2015, TREATMENT WITH CEFTRIAXONE AND VANCOMYCIN ENDED. THE CULTURES WERE NEGATIVE FOR THE FIRST 4 DAYS BUT ON (B)(6) 2015, A COLONY OF PROPIONIBACTERIUM (PROPIONIBACTERIUM INFECTION) WAS FOUND THAT WAS CONFIRMED IN 2 SUCCESSIVE CULTURES. THE CLINICAL CONDITION OF THE SUBJECT WAS REPORTED AS VERY GOOD. ON (B)(6) 2015, AN INCREASE IN CSF (ABOUT 250) WAS NOTED. ON (B)(6) 2015, THE SUBJECT RESTARTED TREATMENT WITH CEFTRIAXONE. AT THE TIME OF THIS REPORT, THE SUBJECT REMAINS HOSPITALIZED. THE OUTCOME OF THE EVENT WAS REPORTED AS NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319273 VENT RES TR RICKHAM LG BA SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPBB2G

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention