BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINETRA

    MDR report key: 625588 · Received August 9, 2005

    Report

    Report Number
    3004209178-2005-01229
    Event Type
    Other
    Date Received
    August 9, 2005
    Report Date
    August 3, 2005
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED PT HAD A SEROMA AND AN INFECTION AND THE ENTIRE BILATERAL DBS SYSTEM WAS EXPLANTED IN 2005. THE DEVICE WAS EXPLANTED AND RETURNED TO THE FMR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA IPG MHY MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other