BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RICKHAM RESEVOIR

    MDR report key: 22864544 · Received August 21, 2025

    Report

    Report Number
    3013886523-2025-00216
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    April 11, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    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

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE RICKHAM RESERVOIR (UNKNOWN ID) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER 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, THE END OF LIFE OF THE DEVICE REPORTED BY THE CUSTOMER COULD BE DUE TO TOO MANY PUNCTURES DONE INTO THE DOME OF THE RESERVOIR. MULTIPLE PUNCTURES AT THE SAME LOCATION CAN INCREASE RISK OF TEARING. 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. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED AND INSTRUCTIONS FOR USE (IFU) WAS UPDATED. CHANGES DONE: - UPDATE OF SECTION WITH CATALOG NUMBER, - UPDATE INJECTION SECTION (PRECAUTION OF 25 PUNCTIONS MAX IN THE DOME, AT MULTIPLES LOCATIONS, TO AVOID ANY RISK OF TEARING), - CORRECT EC REP ADDRESS, - UPDATE SECTION ABOUT TRADEMARKS, - ADD WEBSITE.

    Description of Event or Problem · 0

    STUDY - THIS CASE IS A REPORT REFERRING TO A 12 YEAR OLD MALE PATIENT FROM THE BIOMARIN STUDY, CERLIPONASE ALFA OBSERVATIONAL STUDY. "ON (B)(6) 2017, THE PARTICIPANT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR). THE LOT NUMBER FOR BRINEURA WAS L241273. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2025." "ON (B)(6) 2019, THE PARTICIPANT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (MODEL, LOT, SERIAL AND CATALOG NUMBERS WERE NOT REPORTED)." "ON (B)(6) 2025 AT 9:32, THE PARTICIPANT WAS HOSPITALIZED WITH GRADE 3 DEVICE END OF SERVICE; THE DEVICE WAS REMOVED AND UNAVAILABLE TO BE RETURNED. ON THE SAME DAY, TREATMENT INCLUDED IMPLANTATION OF A NEW LEFT VENTRICULAR ACCESS DEVICE, A CODMAN HOLTER RICKHAM (MODEL 82-1623) 9.5 MM RESERVOIR. THE PARTICIPANT WAS NOTED TO HAVE BEEN AT BASELINE PRIOR TO THE OPERATION. THE PARTICIPANT WAS MONITORED OVERNIGHT. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT." "THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED ON (B)(6) 2025 AT 10:56 AND THE PARTICIPANT WAS DISCHARGED." "THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVICE AS NOT RELATED TO TREATMENT WITH BRINEURA. HOWEVER, THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DEVICE."

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203298 UNKNOWN RICKHAM RESEVOIR RESERVOIRS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention ACETAMINOPHEN (PARACETAMOL)| BACLOFEN (BACLOFEN)| CETIRIZINE (CETIRIZINE HYDROCHLORIDE)| CETIRIZINE (CETIRIZINE HYDROCHLORIDE)| DIASTAT ACUDIAL (DIAZEPAM)| FLUOXETINE (FLUOXETINE HYDROCHLORIDE)| KEPPRA (LEVETIRACETAM)| LEVETIRACETAM (LEVETIRACETAM| LIDOCAINE (LIDOCAINE HYDROCHLORIDE)| MIRALAX (MACROGOL 3350)| ONDANSETRON (ONDANSETRON HYDROCHLORIDE)| RISPERIDONE (RISPERIDONE)| TETRABENAZINE (TETRABENAZINE)| TOPAMAX (TOPIRAMATE)| TOPAMAX (TOPIRAMATE)| VALTOCO (DIAZEPAM)