BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICKHAM RESERVOIR

    MDR report key: 5864651 · Received August 10, 2016

    Report

    Report Number
    1226348-2016-10565
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 7, 2016
    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

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THIS CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION WAS 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. HOWEVER, THE IT WAS REPORTED BY THE INITIAL REPORTED THAT THE PATIENT'S INFECTION WAS RELATED TO THE CODMAN DEVICE. 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. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    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)(4), IS A REPORT FROM (B)(6), REFERRING TO A (B)(6) MALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM (B)(6) TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF INTRACEREBROVENTRICULAR BMN 250 IN PATIENTS WITH MUCOPOLYSACCHARIDOSIS TYPE IIIB (MPS IIIB, SANFILIPPO SYNDROME TYPE B). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED OTITIS MEDIA AND AN EAR TUBE INSERTION. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED MACROCEPHALY, MUCOPOLYSACCHARIDOSIS IIIB, HYPOACUSIS, HEARING AID USE, PSYCHOMOTOR HYPERACTIVITY, AND SPEECH DELAY. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED IBUPROFEN, CEFUROXIME SODIUM, PARACETAMOL, VANCOMYCIN, SUFENTANIL, PROPOFOL, ROCURONIUM, BROMIDE, NITRAZEPAM, DEXAMETHASONE, CEFOTAXIME SODIUM, AND PROCHLORPERAZINE. ON (B)(6) 2016, THE SUBJECT UNDERWENT IMPLANTATION OF AN INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (CODMAN & SHURTLEFF, INC. (B)(4); MODEL 82-1625). THE DEVICE LOT NUMBER WAS NOT REPORTED. AT THE TIME OF THE REPORT, THE SUBJECT HAD NOT YET INITIATED TREATMENT WITH STUDY DRUG. ON (B)(6) 2016, THE SUBJECT WAS DIAGNOSED WITH CONFIRMED ICV INFECTION ((B)(4)). ON (B)(6) 2016, THE SUBJECT EXPERIENCED SUTURE INSUFFICIENCY AND CSF LEAKAGE (CEREBROSPINAL FLUID LEAKAGE) WHICH LEAD TO SURGICAL SUTURE REVISION ON (B)(6) 2016. THE EVENT WAS CONSIDERED GRADE 2 IN SEVERITY. CEFOTAXIME SODIUM TREATMENT WAS RESTARTED ON (B)(6) 2016. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON (B)(6) 2016. THE INVESTIGATOR ASSESSED THE EVENT OF CEREBROSPINAL FLUID LEAKAGE AS RELATED TO THE ICV DEVICE. OTHER ETIOLOGICAL FACTORS INCLUDED THE ICV INFECTION AND EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED. PER INVESTIGATOR: ADDITIONAL INFORMATION RECEIVED ON 21-JUL-2016: ON (B)(6) 2016, FOLLOWING THE CONFIRMATION OF INFECTION, THE ICV DEVICE WAS REMOVED. THE INVESTIGATOR CHANGED THE ASSESSMENT OF THE EVENT OF CEREBROSPINAL FLUID LEAKAGE FROM RELATED TO THE ICV DEVICE TO NOT RELATED TO THE ICV DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517019 RICKHAM RESERVOIR CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO Required Intervention