BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLETRA

    MDR report key: 521687 · Received April 15, 2004

    Report

    Report Number
    6000032-2004-00491
    Event Type
    Other
    Date Received
    April 15, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 18, 2004
    Manufacturer
    MEL REL, INC.
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR REP REPORTED IPG AND EXTENSION WERE REMOVED IN 2003 DUE TO INFECTION. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN ADD'L INFO IS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA IPG MHY MEL REL, INC. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other LEAD MODEL 3387 LOT# J0348830V IMP: 2003| EXP: UNK.| EXP: 2004,| EXT MODEL 7482 LOT# NHU032224V IMP: 2003