BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC LP VALVE

    MDR report key: 2231001 · Received August 26, 2011

    Report

    Report Number
    2021898-2011-00206
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NOT LOT NUMBER WAS PROVIDED. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT'S LP STRATA VALVE CHANGED PERFORMANCE LEVELS SEVERAL TIMES. ACCORDING TO THE REPORT, IT WAS DISCOVERED DURING REVISION OF THE SHUNT THAT THE PROXIMAL CATHETER HAD DISCONNECTED FROM THE VALVE. THE PROXIMAL CATHETER HAD MIGRATED TOWARDS THE PT'S SPINAL CORD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R