BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II UNISHUNT, SMALL

    MDR report key: 2950334 · Received February 6, 2013

    Report

    Report Number
    2021898-2013-00033
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ADD'L DEVICE/PT INFO: THE EXACT DATE OF IMPLANT IS UNK. IT WAS ONLY REPORTED THAT THE DEVICE HAD BEEN IMPLANTED FOR ONE YR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER THE PT TOOK A ROUTINE MRI A MONTH AGO THE SHUNT WAS STUCK BETWEEN PRESSURE LEVEL SETTINGS 2.0 AND 2.5. THE SHUNT WAS EXPLANTED AND REPLACED WITH A NEW MEDTRONIC STRATA SHUNT. THE EXPLANTED SHUNT WAS IMPLANTED A YR AGO. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY OTHER THAN THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49860 STRATA II UNISHUNT, SMALL JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C52475

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R