BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICKHAM RESERVOIR

    MDR report key: 5239784 · Received November 20, 2015

    Report

    Report Number
    1226348-2015-10687
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 20, 2015
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A
    Product Code
    JXG
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND, THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THIS CASE, (B)(4), IS A REPORT FROM (B)(6), REFERRING TO A (B)(6) YEAR-OLD FEMALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE (B)(6) SPONSORED (B)(4) STUDY, A MULTICENTER, MULTINATIONAL, EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF BMN 190 IN PATIENTS WITH CLN2 DISEASE. THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED PROPOFOL ALLERGY. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED INCREASED IRRITABILITY, PSYCHOMOTOR REGRESSION, TREMOR, DYSARTHRIA, GAIT DISTURBANCE, OCULAR SQUINTING, MYOCLONUS, SEIZURE, AND NEURONAL CERIOD LIPOFUSCINOSIS. ALLERGIES INCLUDED PEANUT BUTTER ALLERGY. CONCOMITANT MEDICATIONS INCLUDED LEVETRACETAM, VALPROATE SODIUM, MIDAZOLAM, CHLORPHENAMINE MALEATE, PARACETAMOL, ONDANSETRON, LORAZEPAM, AND DIAZEPAM. ON (B)(6) 2015, A RICKHAM VENTRICULOSTOMY SET, MODEL NUMBER 82-1623 MANUFACTURED BY CODMAN & SHURTLEFF, INC (510K NUMBER K102961) WAS IMPLANTED. THE DEVICE LOT NUMBER WAS CRCB5K, (B)(4). ON (B)(6) 2015, THE SUBJECT INITIATED TREATMENT WITH BMN (300MG, QOW, INTRACICTERNAL). THE LOT NUMBER FOR BMN 190 WAS L241022. THE MOST RECENT DOSE OF BMN 190 WAS ADMINISTERED ON (B)(6)2015. ON (B)(6) 2015, THE SUBJECT EXPERIENCED AN INFECTION OF INTRACEREBROVENTRICULAR (ICV) DEVICE. THE SUBJECT'S WHITE BLOOD CELL (WBC) WAS 32 AND CEREBROSPINAL FLUID (CSF) PROTEIN WAS 11.3 (UNITS AND REFERENCE RANGES NOT PROVIDED). THE DEVICE CULTURE WAS POSITIVE FOR PROPIONIBACTERIUM ACNES. ON (B)(6) 2015 AT 09:45, THE SUBJECT EXPERIENCED A PROPIONIBACTERIUM INFECTION DEVICE (DEVICE RELATED INFECTION) WHICH CAUSED THE SUBJECT'S HOSPITALIZATION. ADDITIONAL LABORATORY / DIAGNOSTIC TESTS INCLUDED ELECTROCARDIOGRAM (ECG), CHEST X-RAY, HEMATOLOGY, AND CHEMISTRY TESTS FOR THE SURGERY (RESULTS NOT PROVIDED). ON (B)(6) 2015, THE DEVICE (RICKHAM VENTRICULOSTOMY SET) WAS REMOVED BY A NEUROSURGEON. TREATMENT FOR THE EVENT INCLUDED MEROPENEM 600 MG, THREE TIMES DAILY (TID). ADDITIONAL TREATMENT INCLUDED SODIUM CHLORIDE, GLUCONATE SODIUM / MAGNESIUM CHLORIDE ANHYDROUS / POTASSIUM CHLORIDE / SODIUM ACETATE /SODIUM CHLORIDE, SEVOFLURANE, FENTANYL, ROCURONIUM BROMIDE, AND SODIUM CHLORIDE COMPOUND INJECTION. THE SUBJECT WAS REPORTED TO BE IN GOOD CONDITION BUT REMAINED IN THE HOSPITAL FOR OBSERVATION AND CONTINUED ANTIBIOTIC AND FLUID THERAPY. NO ACTION WAS TAKEN WITH BMN 190 DUE TO THE EVENT. THE OUTCOME FO THE EVENT WAS REPORTED AS NOT RECOVERED / NOT RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BMN 190. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DEVICE. NO OTHER ETIOLOGICAL FACTORS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IT RECEIVED, THE REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769637 RICKHAM RESERVOIR CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention