BEUDAMED
    FDA Adverse Event Summary report: N

    STRATA, ADJUSTABLE VALVE

    MDR report key: 595599 · Received April 18, 2005

    Report

    Report Number
    2021898-2005-00060
    Date Received
    April 18, 2005
    Date of Event
    February 22, 2005
    Report Date
    March 21, 2005
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE WAS A SUBCUTANEOUS SWELLING AROUND THE VALVE, AND IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA, ADJUSTABLE VALVE CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND CO JXA MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *