BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENT RES TR RICKHAM ST BA

    MDR report key: 18160319 · Received November 17, 2023

    Report

    Report Number
    3013886523-2023-00405
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    May 10, 2023
    Report Date
    January 4, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K102961
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI) : (B)(4). ROOT CAUSE UPDATE: THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE DESCRIPTION OF THE COMPLAINT, NO DEFECT WAS REPORTED ON A INTEGRA DEVICE, AS NOTED IN THE COMPLAINT, THE MALFUNCTION IS REPORTED ON THE OMMAYA DEVICE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    UDI : (B)(4). THE RICKHAM RESERVOIR (ID 821621) 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. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE MECHANISM. 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.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    MEDWATCH - US-2023-153448. STUDY - THIS CASE IS A REPORT REFERRING AN 8 YEAR-OLD FEMALE SUBJECT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. THE PATIENT'S PAST MEDICAL PROCEDURE CEREBROSPINAL FLUID RESERVOIR PLACEMENT. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CEREBELLAR ATROPHY, EPILEPSY, NEURONAL CEROID LIPOFUSCINOSIS AND DEVELOPMENTAL DELAY. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED PARACETAMOL, IBUPROFEN AND LORAZEPAM. ON (B)(6) 2019 THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRISCULOSTOMY (ICV) SET (CODMAN GENERIC). THE LOT NUMBER, SERIAL NUMBER AND CATALOG NUMBER WAS UNKNOWN. THE MODEL NUMBER WAS 821621. ON (B)(6) 2019, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS UNKNOWN. THE MOST RECENT DOSE OF BRINEURA WAS ADMINISTERED ON (B)(6) 2023. ON (B)(6) 2023 THE SUBJECT PRESENTED FOR HER BRINEURA QOW INFUSION AND AT 10:39 THE SUBJECT EXPERIENCED GRADE 4 OMMAYA MALFUNCTION (DEVICE MALFUNCTION) AND WAS HOSPITALIZED ON THE SAME DATE DUE TO THE EVENT. AT 10:39, THE SUBJECT UNDERWENT A COMPUTERISED TOMOGRAM (CT) OF THE HEAD. THE CT IMPRESSION SHOWED RIGHT FRONTAL OMMAYA WHICH APPEARED STABLE IN POSITION COMPARED TO (B)(6) 2020. MILD INCREASED CEREBELLAR ATROPHY AND STABLE SUPRATENTORIAL VENTRICULAR/SULCAL PROMINENCE. THE SUBJECT WAS ADMITTED TO 10WT. ON (B)(6) 2023 THE SUBJECT WAS TAKEN TO THE OPERATING ROOM (OR) AND UNDERWENT OMMAYA REPLACEMENT. THE OPERATOR OF THE ICV WAS THE INVESTIGATOR, THE LOCATION WAS AT THE CLINIC AND THE ICV DEVICE WAS NOT AVAILABLE FOR RETURN. THE WAS NO INTRA-OPERATIVE COMPLICATIONS AND THE SUBJECT TOLERATED THE PROCEDURE WELL AND RETURNED TO 10WT. ON AN UNREPORTED DATE, REPORTED AS THE DATE OF DISCHARGE, THE SUBJECT WAS AFEBRILE, TOLERATING ORAL, WITH STABLE NEUROLOGICAL EXAM AND STABLE VITAL SIGNS. THE SUBJECT WAS CLEARED FOR DISCHARGE. NO ADDITIONAL TREATMENT FOR THE EVENT WAS REPORTED. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON (B)(6) 2023. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE MALFUNCTION AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE MALFUNCTION AS RELATED TO THE ICV DEVICE. OTHER ETIOLOGICAL FACTORS INCLUDED THE DEVICE END-OF-LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED. CASE COMMENT: THE PATIENT EXPERIENCED DEVICE MALFUNCTION, WHICH IS A KNOWN COMPLICATION OF ICV DEVICE USE. ICV DEVICE WAS IMPLANTED AROUND 3.5 YEARS BEFORE THE EVENT, WHICH IS NEAR TO END OF LIFE CYCLE (4 YEARS) OF ICV DEVICE. THE CAUSALITY OF EVENT IS ASSESSED AS NOT RELATED TO BRINEURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863497 VENT RES TR RICKHAM ST BA RESERVOIRS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female ACETAMINOPHEN (PARACETAMOL),| CETIRIZINE (CETIRIZINE HYDROCHLORIDE) 1,| CLONAZEPAM (CLONAZEPAM),| DIAZEPAM (DIAZEPAM),| IBUPROFEN (IBUPROFEN),| LEVETIRACETAM (LEVETIRACETAM),| LEVOCARNITINE (LEVOCARNITINE HYDROCHLORIDE),| LORAZEPAM (LORAZEPAM),| MULTIVITAMIN (VITAMINS NOS),| OXCARBAZEPINE (OXCARBAZEPINE),| VALPROIC ACID (VALPROATE SODIUM),