BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RICKHAM RESEVOIR

    MDR report key: 18221101 · Received November 28, 2023

    Report

    Report Number
    3013886523-2023-00393
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    September 25, 2023
    Report Date
    February 9, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE RICKHAM RESERVOIR WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE "DEVICE LEAKAGE" COULD NOT BE CLEARLY DETERMINED BUT COULD BE LINKED TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE, AS NOTED IN THE INSTRUCTIONS FOR USE (IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    MEDWATCH US-2023-152978 STUDY - THIS CASE IS A REPORT REFERRING TO A 22 MONTH OLD FEMALE PATIENT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED: HYPERBILIRUBINAEMIA AND MEDICAL DEVICE IMPLANTATION. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED: HYPERSENSITIVITY, NEURONAL CEROID LIPOFUSCINOSIS, PAIN, AND HYPERREFLEXIA. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATION INCLUDED: PARACETAMOL, DIPHENHYDRAMINE HYDROCHLORIDE AND LIDOCAINE ON AN UNREPORTED DATE, THE SUBJECT UNDERWENT IMPLANTATION WITH AN UNSPECIFIED CODMAN ICV DEVICE (N/A). MODEL, LOT AND SERIAL NUMBERS NOT PROVIDED. ON AN UNREPORTED DATE, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR USE). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT'S BRINEURA INFUSION WAS ADMINISTERED. THE SUBJECT MOVED QUITE A BIT AFTER FIRST ACCESS, WITH XANTHOCHROMIC CEREBROSPINAL FLUID AND NEEDLE DISLODGING, BUT NO LEAK VISUALIZED, AND ON REPEAT ATTEMPT WITH CLEAR CEREBROSPINAL FLUID AND NO PROBLEMS DURING THE INFUSION. AFTER AN UNSPECIFIED AMOUNT OF TIME, AFTER WAKING PATIENT UP FROM NAP, CLEAR LEAKAGE FROM THE RIGHT SCALP INSERTION SITE WAS DISCOVERED (DEVICE LEAKAGE). THE INTENSITY OF THE EVENT WAS REPORTED AS GRADE 1. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. TREATMENT FOR THE EVENT INCLUDED OCRILATE. THE ACTION TAKEN WITH BRINEURA DUE TO THE EVENT WAS REPORTED AS NOT APPLICABLE. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING OR RESOLVING. BIOMARIN HAS ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE LEAKAGE AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE LEAKAGE AS RELATED TO THE SUBJECT'S ICV DEVICE. NO OTHER ETIOLOGICAL FACTORS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023 ADDITIONAL CONCOMITANT MEDICATION INCLUDED CERLIPONASE ALFA. THE PATIENT'S PREMEDICATION INCLUDED PARACETAMOL, DIPHENHYDRAMINE HYDROCHLORIDE AND LIDOCAINE. ON (B)(6)2023, THE PATIENT INITIATED TREATMENT WITH BRINEURA. THE INTENSITY PREVIOUSLY REPORTED AS GRADE 1 HAS BEEN UPDATED BY THE INVESTIGATOR TO GRADE 3. ON AN UNREPORTED DATE, THE PATIENT VISITED THE NEUROSURGEON, AND A SLOW OOZING WAS DISCOVERED. TREATMENT INCLUDED DERMABOND. THE PATIENT'S MOTHER DENIED CHANGE IN ACTIVITY OR APPETITE, FEVER OR CHILLS, COUGH, CONGESTION OR DYSPNEA. ON (B)(6)2023, THE SUBJECT WAS DISCHARGED. ON (B)(6)2023 THE SUBJECT HAD ONGOING CEREBROSPINAL FLUID LEAKAGE THAT REQUIRED HOSPITALIZATION AND RESERVOIR REPLACEMENT SURGERY. (B)(6)2023 A REPLACEMENT RESERVOIR WAS IMPLANTED (17 MM SS HOLTER RICKHAM - S) ON THE LEFT SIDE. THE LOT NUMBER OF THE DEVICE WAS REPORTED AS 4837377. ON (B)(6)2023, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED OR RESOLVED ON(B)(6)2023. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023 ON (B)(6)2023 THE SUBJECT PRESENTED ONSITE FOR THE BRINEURA INFUSION. THE INJECTION WAS COMPLETED SUCCESSFULLY AND THERE WAS NOT A NEW ADVERSE EVENT RESULTING FROM THE INITIAL SERIOUS ADVERSE EVENT. CASE COMMENT: THE PATIENT EXPERIENCED DEVICE LEAKAGE AFTER PATIENT MOVED QUITE A BIT AFTER FIRST ACCESS, WHICH IS A KNOWN COMPLICATION OF ICV DEVICE USE. THE CAUSALITY OF DEVICE LEAKAGE IS ASSESSED AS NOT RELATED TO BRINEURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898359 UNKNOWN RICKHAM RESEVOIR RESERVOIRS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Female ACETAMINOPHEN (PARACETAMOL).| DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE).| LIDOCAINE (LIDOCAINE).