BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LP STRATA NSC SHUNT KIT

    MDR report key: 2994387 · Received March 5, 2013

    Report

    Report Number
    2021898-2013-00079
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K123524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. INITIALLY THE VALVE WAS UNADJUSTED, BUT AFTER THE PATENCY TREAT WAS PERFORMED THE VALVE REGAINED ITS ADJUSTABILITY. THE VALVE MET REQUIREMENTS FOR THE LEAKAGE AND PREIMPLANTATION TEST. IT HOWEVER DID NOT MEET REQUIREMENT FOR THE REFLUX AND ALL OF THE PRESSURE-FLOW TESTS. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE VALVE MECHANISM RESULTING IN REFLUX, PREVENT ADJUSTMENT OF THE VALVE MECHANISM, AS WELL AS HINDER FLUID FLOW THROUGH THE VALVE RESULTING IN HIGH PRESSURE FLOW RESULTS. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. THE LUMBER CATHETER WAS RETURNED IN TWO PIECES OF LENGTHS 21 CM AND 13.1 CM. THE CATHETER APPEARED TO BE CUT AT THE LOCATION OF THE FIXATION TAB. BOTH PIECES OF THE CATHETER MET REQUIREMENTS FOR THE PATENCY AND LEAKAGE TESTS. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. A 43.6 CM OF THE PERITONEAL CATHETER WAS RETURNED. THE CATHETER MET REQUIREMENTS FOR THE PATENCY AND LEAKAGE TESTS. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A LP STRATA NSC SHUNT KIT WAS EXPLANTED FROM A PT BECAUSE THE PT WAS EXPERIENCING PAIN IN A NERVE ROOT DUE TO THE PLACEMENT OF THE CATHETER. THE SHUNT WAS SAID TO BE "WORKING GREAT" AND THAT THERE WERE "NO PROBLEMS WITH THE SHUNT." IT WAS ALSO REPORTED THAT THE PT IS DOING WELL AND WAS DISCHARGED THE SAME DAY AS THE EXPLANTATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94315 LP STRATA NSC SHUNT KIT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization