BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA II SHUNT

    MDR report key: 1910664 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00321
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    May 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE HAD A STRATA II VP SHUNT SINCE (B)(6) 2009 FOR NORMAL PRESSURE HYDROCEPHALUS. FAILURE OF THE VALVE REQUIRED A REPLACEMENT (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA II SHUNT JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R