BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICKHAM RESERVOIR

    MDR report key: 6667121 · Received June 26, 2017

    Report

    Report Number
    1226348-2017-10443
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 22, 2017
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED. SUBSEQUENTLY IT WAS COMMUNICATED THE DEVICE WOULD NOT BE MADE AVAILABLE. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6) STUDY, AFTER RICKMAN VENTRICULOSTOMY SET, (B)(4), INSERTION, THE PATIENT DEVELOPED AN INFECTION. THIS CASE, (B)(4), IS A REPORT FROM THE UNITED STATES, REFERRING TO A (B)(6) FEMALE SUBJECT ((B)(6)). AN INVESTIGATOR REPORTED THIS CASE FROM THE (B)(6) STUDY, A MULTICENTER, MULTI-NATIONAL OPEN-LABEL PROGRAM TO PROVIDE BMN 190 TO PATIENTS DIAGNOSED WITH CLN2 DISEASE. THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GASTROSCHISIS. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED ATAXIA, INSOMNIA, NEURONAL CEROID LIPOFUSCINOSIS, PROPIONIBACTERIUM INFECTION AND LANGUAGE DISORDER. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED MALTGDEXTRIN, RETINOL, CURCUMA LONGA RHIZOME, BENZYLPENICILLIN SODIUM, MAGNESIUM, ERGOCALCIFEROL, AND PARACETAMOL. PRE-MEDICATIONS PRIOR TO BMN 190 INFUSIONS INCLUDED PARACETAMOL AND CETIRIZINE HYDROCHLORIDE. ON AN UNSPECIFIED DATE, A RICKHAM VENTRICULOSTOMY SET, MODEL 82-1625, MANUFACTURED BY CODMAN AND SHURTLEFF WAS IMPLANTED. THE DEVICE NUMBER, UDI NUMBER, AND SERIAL NUMBER WERE NOT REPORTED. ON (B)(6) 2016, THE SUBJECT INITIATED TREATMENT WITH BMN 190 (300 MG, QOW, INTRACISTERNAL). THE LOT NUMBER FOR BMN 190 WAS L241036. THE MOST RECENT DOSE OF BMN 190 WAS ADMINISTERED ON (B)(6) 2017. ON (B)(6) 2017 AT 08:00, THE SUBJECT EXPERIENCED A GRADE 1 DEVICE-RELATED INFECTION (DEVICE RELATED INFECTION). IT WAS REPORTED THAT THE DEVICE WAS PRESUMPTIVELY INFECTED AS AT 72 HOURS FROM THE SUBJECT'S DEVICE ACCESS AND BMN 190 INFUSION ON (B)(6) 2017, THE INVESTIGATOR WAS NOTIFIED OF A POSITIVE CULTURE IN THIOGLYCOLLATE BROTH. IDENTIFICATION OF THE PATHOGEN WAS IN PROCESS. THE SUBJECT WAS ASYMPTOMATIC WITH NO FEVER OR HEADACHE NOTED. CEREBROSPINAL (CSF) GLUCOSE, PROTEIN, AND CELL COUNT WERE NORMAL. ON (B)(6) 2017, THE SUBJECT HAD A REPEAT DEVICE ACCESS AND A SECOND CULTURE HAD BEEN OBTAINED (AWAITING RESULTS). NO TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BMN 190 DUE TO THE EVENT. ON (B)(6) 2017 AT 12:12, THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED. BIOMARIN HAS ASSESSED THIS EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS RELATED TO TREATMENT WITH BMN 190 AND TO THE DEVICE. OTHER ETIOLOGICAL FACTORS INCLUDED UNSPECIFIED BACTERIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED. ADDITIONAL INFORMATION RECEIVED ON 09-JUN-2017: THE PREVIOUSLY REPORTED EVENT OF DEVICE-RELATED INFECTION (DEVICE RELATED INFECTION) WAS UPDATED BY THE INVESTIGATOR TO FALSE POSITIVE CSF CULTURE (FALSE POSITIVE INVESTIGATION RESULT). ON 03-OCT-2016 (PREVIOUSLY NOT REPORTED), A RICKHAM VENTRICULOSTOMY SET, MODEL (B)(4), MANUFACTURED BY CODMAN AND SHURTLEFF WAS IMPLANTED. THE SERIAL NUMBER WAS (B)(4) AND CATALOG NUMBER WAS (B)(4). ON (B)(6) 2017 RESPECTIVELY, SUBSEQUENT FINAL CSF CULTURES WERE BOTH NEGATIVE. THE INVESTIGATOR REPORTED THIS AS A FALSE POSITIVE OR CONTAMINANT CULTURE (FALSE POSITIVE INVESTIGATION RESULT). NO TREATMENT WAS PROVIDED. BIOMARIN NO LONGER CONSIDERED THIS EVENT AS MEDICALLY SIGNIFICANT. THE DEVICE HAS NOT BEEN REMOVED NOR RETURNED. THE INVESTIGATOR ASSESSED THE EVENT OF FALSE POSITIVE INVESTIGATION RESULT AS RELATED TO TREATMENT WITH BMN 190 AND TO THE DEVICE. OTHER ETIOLOGICAL FACTORS INCLUDED UNSPECIFIED BACTERIA. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448714 RICKHAM RESERVOIR CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention