BEUDAMED
    FDA Adverse Event Other Summary report: N

    CSF-VENTRICULAR CATHETER, STANDARD, 23CM

    MDR report key: 2470689 · Received February 24, 2012

    Report

    Report Number
    2021898-2012-00041
    Event Type
    Other
    Date Received
    February 24, 2012
    Report Date
    January 30, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE REPORTED EVENT IS UNK. THE PRODUCT WAS NOT RETURNED TO THE MFR AS IT REMAINS IMPLANTED. THEREFORE AN EVAL OF THE DEVICE WAS NOT POSSIBLE. A REVIEW OF THE MFG AND STERILIZATION RECORDS SHOWED NO ANOMALIES. NO INJURY TO THE PT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT DEVELOPED A GRANULOMA ALONG THE VENTRICULAR CATHETER AFTER AN OMMAYA RESERVOIR PROCEDURE. ACCORDING TO THE REPORT, THE DEVICE REMAINS IMPLANTED AND THE PT DID NOT NEED ADD'L TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-VENTRICULAR CATHETER, STANDARD, 23CM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C02801

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other