BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1841954 · Received September 21, 2010

    Report

    Report Number
    2021898-2010-00228
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE, AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY TECH CHECKED ON THE CUSTOMER SEVERAL TIMES, AND THE VALVE KEPT SELF-ADJUSTING. THE VALVE WAS EXPLANTED ON (B)(6) 2010, AND THE PT IMPROVED WITH A NEW VALVE. THE STRATA VALVE WAS UNKNOWINGLY ADJUSTING WAY TOO OFTEN FOR THE PATIENT, AND THE SURGEON'S SATISFACTION. NO DEATH OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R