BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-PERITONEAL CATHETER, STANDARD, OPEN END

    MDR report key: 1910676 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00316
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    October 16, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS NOT RELATED TO A MALFUNCTION OF THE DEVICE. SINCE THE PRODUCT REMAINS IMPLANTED, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A PT FAMILY MEMBER REPORTED THAT HE HAS AN (B)(6) BOY WHO HAS HAD A SHUNT SINCE HE WAS (B)(6). THE DISTAL CATHETER HAD TO BE REPLACED DUE TO SCAR TISSUE ADHERING TO THE CATHETER TUBE IN (B)(6) 2009, AND NOW HE HAS THE SAME PROBLEM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-PERITONEAL CATHETER, STANDARD, OPEN END JXG MEDTRONIC NEUROSURGERY NA C31486

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R