BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RICKHAM RESEVOIR

    MDR report key: 17977795 · Received October 20, 2023

    Report

    Report Number
    3013886523-2023-00348
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 20, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI): (B)(4). THE RICKHAM RESERVOIRS (ID (B)(6)) 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. 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

    BIOMARIN STUDY: CERLIPONASE ALFA OBSERVATIONAL STUDY. CASE DESCRIPTION: THIS CASE REFERS TO A 19 YEAR-OLD MALE SUBJECT. "THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED COVID-19. THE SUBJECT'S PAST MEDICAL PROCEDURES INCLUDED MEDICAL DEVICE IMPLANTATION. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED DYSARTHRIA, INTELLECTUAL DISABILITY, GAIT DISTURBANCE, HYPERTONIA, BLOOD CHOLESTEROL INCREASED, NEURONAL CEROID LIPOFUSCINOSIS, MUSCLE SPASTICITY, SEIZURE, ATAXIA, HEART RATE NORMAL AND KNEE DEFORMITY. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED LEVETIRACETAM, GEMFIBROZIL, NUTRIENTS NOS, IBUPROFEN, TRIHEXYPHENIDYL HYDROCHLORIDE. PREMEDICATION INCLUDED PARACETAMOL, CETIRIZINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, RIFAMPICIN, VANCOMYCIN HYDROCHLORIDE. ON AN UNREPORTED DATE, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRISCULOSTOMY (ICV) SET (CODMAN, RICKHAM). THE MODEL NUMBER WAS 82-1623. THE LOT NUMBER WAS NOT REPORTED." "ON (B)(6) 2017, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS L241238." "ON (B)(6) 2018, THE CURRENT ICV DEVICE WAS IMPLANTED." "ON 17-AUG-2023 AT 15:02, THE SUBJECT RECEIVED THE MOST RECENT DOSE OF BRINEURA. ON 31-AUG-2023 AT 07:54, THE SUBJECT EXPERIENCED GRADE 1 DEVICE RELATED INFECTION. ON THE SAME DATE, A CSF CULTURE WAS COLLECTED WHICH SHOWED RARE WHITE BLOOD CELLS AND NO ORGANISM WAS SEEN. ON 04-SEP-2023, THE CSF CULTURE WAS POSITIVE AND SHOWED SCANT GROWTH OF STAPHYLOCOCCUS CAPITIS. NO TREATMENT WAS GIVEN FOR THE EVENT. THE ICV DEVICE WAS NOT AVAILABLE FOR RETURN AND THE OPERATOR WAS THE NEUROSURGEON. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT." "THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING." "BIOMARIN PHARMACEUTICAL HAS ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT." "THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS RELATED TO THE ICV DEVICE. OTHER ETIOLOGICAL FACTORS INCLUDED THAT THE EVENT WAS MORE LIKELY RESULTED FROM THE DEVICE SINCE THE DEVICE WAS IMPLANTED ON (B)(6) 2018." CASE COMMENT: "THE PATIENT EXPERIENCED DEVICE RELATED INFECTION, WHICH IS A KNOWN COMPLICATION OF ICV DEVICE USE. THE CAUSALITY OF EVENT IS ASSESSED AS NOT RELATED TO BRINEURA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962998 UNKNOWN RICKHAM RESEVOIR RESERVOIRS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male ACETAMINOPHEN (PARACETAMOL)| CETIRIZINE| GEMFIBROZIL| IBUPROFEN| KEPPRA (LEVETIRACETAM) ONGOING| KETOVIE 4:1| LIDOCAINE| ONDANSETRON| RIFAMPIN| TRIHEXYPHENIDY| VANCOMYCIN