BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL 3

    MDR report key: 593766 · Received June 8, 2004

    Report

    Report Number
    6000032-2004-00741
    Event Type
    Other
    Date Received
    June 8, 2004
    Report Date
    May 10, 2004
    Manufacturer
    MEL REL, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTS THAT THEY GET SHOCKS WHEN GOING THROUGH THEFT DETECTORS. THIS OCCURS WHEN STIMULATION IS ON. A FOLLOW UP REPORT WILL BE SENT WHEN ADD'L INFO IS OBTAINED.

    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 32 YR Other 1. LEAD: MODEL 3987, LOT# NBC002026N, IMP: 2002,| EXPL: UNK.| EXPL: UNK.| IMPL: 2002,| 2. EXTENSION: MODEL 7496-25, LOT# NAG002451N,