BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENT RES TR RICKHAM ST BA

    MDR report key: 16409804 · Received February 21, 2023

    Report

    Report Number
    3013886523-2023-00045
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 20, 2023
    Report Date
    December 8, 2023
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    UDI-DI
    10886704040507
    PMA / PMN Number
    K102961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED 11/21/2023 2:33 AM: THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED TWO EPISODES OF COVID-19. ADDITIONAL CONCOMITANT MEDICATION INCLUDED FACTOR VIII (ANTIHAEMOPHILIC FACTOR)/ VON WILLEBRAND FACTOR. THE LOT NUMBER FOR BRINEURA WAS L241230. OTHER RELEVANT HISTORY: # START/STOP DATE: CONDITION TYPE / CONDITION. * (B)(6) 2021 TO (B)(6) 2021 - HISTORICAL CONDITION COVID -19. * (B)(6) 2022 TO (B)(6) 2022 - HISTORICAL CONDITION COVID -19. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: HUMATE-P (FACTOR VIII (ANTIHAEMOPHILIC FACTOR), VON WILLEBRAND FACTOR) (B)(6) 2023 TO (B)(6) 2023.

    Additional Manufacturer Narrative · 0

    THE RICKHAM RESERVOIR (ID 821621) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. 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.

    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

    N/A.

    Description of Event or Problem · 0

    HOLD RH 2.22.23 STUDY: 6 YEAR-OLD FEMALE PATIENT. (B)(6) STUDY: (B)(6). "THE SUBJECT'S PAST MEDICAL HISTORY WAS NOT REPORTED. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED: CSF LYMPHOCYTE COUNT INCREASED, NEURONAL CEROID LIPOFUSCINOSIS, CONSTIPATION, CARNITINE DECREASED AND EPILEPTIC ENCEPHALOPATHY. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATION INCLUDED: CLOBAZAM, LEVOCARNITINE HYDROCHLORIDE, "CHLORHEXIDINE GLUCONATE", COLECALCIFEROL, DOCUSATE SODIUM, ASCORBIC ACID, BIOTIN, CALCIUM CARBONATE, CALCIUM PANTOTHENATE, CALCIUM PHOSPHATE, CHOLINE CHLORIDE, CHROMIC CHLORIDE, COLECALCIFEROL, COPPER SULFATE, DL-ALPHA TOCOPHERYL ACETATE, FATS NOS, FERROUS SULFATE, FOLIC ACID, INOSITOL, LEVOCARNITINE, MAGNESIUM PHOSPHATE, MANGANESE SULFATE, NICOTINAMIDE, PHYTOMENADIONE, POTASSIUM CHLORIDE, POTASSIUM HYDROXIDE, POTASSIUM IODIDE, PROTEINS NOS, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN, SODIUM MOLYBDATE, SODIUM SELENATE, TAURINE, THIAMINE HYDROCHLORIDE, VITAMIN B12 NOS, ZINC SULFATE, MACROGOL 3350, VALPROATE SEMISODIUM, PYRIDOXINE HYDROCHLORIDE, LEVETIRACETAM AND DIAZEPAM. PARACETAMOL, LIDOCAINE/PRILOCAINE AND CETIRIZINE HYDROCHLORIDE WERE USED AS PREMEDICATION FOR THE SUBJECT'S BRINEURA INFUSIONS." ON (B)(6) 2020, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET, (CODMAN HOLTER RICKHAM RESERVOIR - 6 MILLIMETER). THE LOT NUMBER WAS 4267695. THE OPERATOR OF THE ICV DEVICE WAS AN UNSPECIFIED HEALTHCARE PROFESSIONAL. ON (B)(6) 2020, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2021. ON (B)(6) 2023 AT 15:00, THE SUBJECT EXPERIENCED DEVICE END OF LIFE - REPLACEMENT (DEVICE END OF SERVICE). THE SEVERITY OF THE EVENT WAS NOT REPORTED. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. ON (B)(6) 2023, THE SUBJECT WAS HOSPITALIZED WHERE TREATMENT INCLUDED REMOVAL AND REPLACEMENT OF THE DEVICE. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVICE AS NOT RELATED TO TREATMENT WITH BRINEURA. NO OTHER ETIOLOGICAL FACTORS WERE REPORTED. THE OUTCOME OF THE EVENT WAS UPDATED FROM RECOVERING/RESOLVING TO RECOVERED/RESOLVED ON JANUARY 23, 2023. OTHER ETIOLOGICAL FACTORS INCLUDED IT WAS RELATED TO THE DEVICE. CASE COMMENT: ICV DEVICE WAS PROPHYLACTICALLY REPLACED DUE TO END OF LIFE CYCLE OF DEVICE. IT IS USUALLY DUE TO MATERIAL DEGRADATION OF DEVICE BECAUSE OF LONG PERIODS OF USE. THE CAUSALITY OF EVENT IS ASSESSED AS NOT RELATED TO BRINEURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407349 VENT RES TR RICKHAM ST BA RESERVOIRS JXG RAYNHAM 82-1621 4267695 10886704040507

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female 14) HUMATE-P (FACTOR VIII (ANTIHAEMOPHILIC FACTOR)| ACETAMINOPHEN (PARACETAMOL) 01/27/2021 TO ONGOING| CLOBAZAM (CLOBAZAM) 04/27/2021 TO ONGOING| COLACE (DOCUSATE SODIUM) 10/05/2021 TO ONGOING| DEPAKOTE SPRINKLE (VALPROATE SEMISODIUM)| DIASTAT (DIAZEPAM| EMLA (LIDOCAINE, PRILOCAINE) 03/18/2020 TO ONGOING| KEPPRA (LEVETIRACETAM)| LEVOCARNITINE HYDROCHLORIDE TO ONGOING| MIRALAX (MACROGOL 3350) 01/11/2022 TO ONGOING| PEDIASURE GROW & GAIN 04/12/2021 TO ONGOING| VITAMIN B-6 (PYRIDOXINE HYDROCHLORIDE)| VITAMIN D3 (COLECALCIFEROL) 11/15/2022 TO ONGOING| ZYRTEC (CETIRIZINE HYDROCHLORIDE)