BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL 3

    MDR report key: 525759 · Received May 17, 2004

    Report

    Report Number
    6000032-2004-00619
    Event Type
    Other
    Date Received
    May 17, 2004
    Date of Event
    April 28, 2004
    Report Date
    April 28, 2004
    Manufacturer
    MEL REL, INC
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED PT PRESENTED IN 2001 WITH SIGNS OF AN INFECTION OF THE DEVICE POCKET AND LUMBAR REGION. THESE INCLUDE REDNESS, SWELLING, DRAINAGE, PAIN, INCISIONAL WOUND OPENING, AND POCKET EROSION. CULTURES OF THE DEVICE POCKET AND LUMBAR REGION SHOWED NO ORGANISMS CULTURED. THE PT WAS TREATED WITH WOUND PACKING. HCP REPORTS PT'S INFECTION RESOLVED. NO REPORT OF DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 IPG GZB MEL REL, INC 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other LEAD: MODEL 3887, LOT# J0120514V, IMPLANT: 2001,| EXTENSION: MODEL 7495LZ, LOT# NHK000295V, IMP:2001| EXPLANT: UNK.| EXP: UNK.