BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 3060038 · Received April 11, 2013

    Report

    Report Number
    2021898-2013-00136
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVAL OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN ASSESSED THAT THE DEVICE WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED. THE REPORT STATED THAT THE PT HAD NON-COMMUNICATING HYDROCEPHALUS. REPORTEDLY, THE PT ACQUIRED VENTRICULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155029 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D19907

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R