BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI-SIPHON DEVICE

    MDR report key: 2831303 · Received November 5, 2012

    Report

    Report Number
    2648988-2012-00045
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 5, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K760785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AN (B)(4) "ANTI SIPHON DEVICE WAS IMPLANTED IN A PT WITH SOPHYSA'S VALVE SPV AND ITS PROXIMAL AND DISTAL CATHETERS: PL05 AND B905S ON (B)(6) 2012. HOWEVER, CEREBROSPINAL FLUID (CSF) STARTED TO ACCUMULATE FROM THE PUNCTURED AREA OF VENTRICLE TO BEHIND THE EAR AT THE SUBCUTANEOUS LEVEL. SINCE THAT CAUSED HYPODRAINAGE AND ENLARGEMENT OF THE VENTRICLE, THE SURGEON REPLACED ALL OF THEM WITH A NEW SET OF THE SAME ITEMS, WHICH HAVE BEEN FUNCTIONING PROPERLY. THERE WAS NEITHER CONNECTION TROUBLE NOR KINK OF THE CATHETERS. NO DEPOSIT WAS SEEN IN THE SYSTEM. PROTEIN AND THE NUMBER OF CELLS IN CSF ARE NORMAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-SIPHON DEVICE N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO