BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIAL DEVICE UNITIZED PROGRA

    MDR report key: 18229652 · Received November 29, 2023

    Report

    Report Number
    3013886523-2023-00401
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 2, 2023
    Report Date
    February 14, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    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

    HAKIM VALVE (ID NS9008) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE NS9008 WITH LOT 6791510, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 30 MMH2O. THE VALVE WAS VISUALLY INSPECTED AND NO DEFECT WAS NOTED. THE VALVE WAS HYDRATED. THE CATHETERS WERE IRRIGATED AND NO OCCLUSIONS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS -THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE AND THE CATHETER.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID (B)(4) WAS IMPLANTED ON UNKNOWN DATE WITH UNKNOWN SETTING VIA LUMBAR PERITONEAL (LP) SHUNT. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AFTER A SURGERY, THERE WAS A SIGN OF NO FLOW OF CEREBROSPINAL FLUID (CSF). THE VALVE WAS REPLACED WITH ANOTHER PRODUCT DUE TO SUSPICION OF BLOCKAGE OF BOTH VALVE AND CATHETER. THE PATIENT IS STABLE AND HAS RECOVERED. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN WHEN WAS THE EXPLANT DATE AND THEY CANNOT CONFIRM IF THE CATHETER IS A COMPONENT OF THE HAKIM VALVE. PRIMARY DISEASE SUBARACHNOID HEMORRHAGE (SAH).

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920551 SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6791510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 702-JJ SILASCON® LUMBAR CATHETER