BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

    MDR report key: 3084157 · Received April 18, 2013

    Report

    Report Number
    2021898-2013-00146
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    April 2, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S PHYSICIAN CONFIRMED THAT THE REVISION SURGERY WAS PERFORMED DUE TO THE DISTAL TUBING HAVING PULLED OUT OF THE ABDOMEN. THE PHYSICIAN ALSO REPORTED THAT THIS WAS NOT A DEVICE PROBLEM. THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY BY THE PT THAT HE HAD A LUMP ON HIS ABDOMEN AROUND THE SIZE OF AN EGG. ACCORDING TO THE REPORT, IT WAS DETERMINED BY HIS PHYSICIAN THAT THE TUBING HAD RETRACTED AND WAS SITTING ABOVE THE ABDOMINAL MUSCLE. THE REPORT STATED THAT THE PT UNDERWENT A REVISION SURGERY TO HAVE THE TUBING PUT IN PLACE. THE PT STATED THAT HE IS CURRENTLY OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167644 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R