BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1943968 · Received December 3, 2010

    Report

    Report Number
    2021898-2010-00340
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SHOWED NO ANOMALIES. NO IMPACT TO THE PT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR PERFORMED TESTING, THERE WAS A LEAK IN THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C58129

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK