BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERSTIM

    MDR report key: 647989 · Received November 21, 2005

    Report

    Report Number
    6000032-2005-01824
    Event Type
    Other
    Date Received
    November 21, 2005
    Date of Event
    August 25, 2004
    Report Date
    October 24, 2005
    Manufacturer
    MEL REL, INC.
    Product Code
    EZW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HCP REORTED THAT THE PT DEVELOPED AN INFECTION OF THE DEVICE POCKET WITH REDNESS, SWELLING AND DRAINAGE. CULTURES WERE TAKEN BUT THE RESULTS ARE UNKNOWN. THE DEVICE SYSTEM WAS EXPLANTED AND THE INFECTION IS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM IPG EZW MEL REL, INC. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other