BEUDAMED
    FDA Adverse Event Other Summary report: N

    IROX

    MDR report key: 92126 · Received May 16, 1997

    Report

    Report Number
    1640319-1997-00444
    Event Type
    Other
    Date Received
    May 16, 1997
    Date of Event
    April 17, 1997
    Report Date
    May 16, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT NECESSARY TO RETURN THE DEVICE TO THE MFR. AN INVESTIGATION WAS PERFORMED AND BELOW ARE THE RESULTS. THE SUBJECT LEAD WENT INTO "FINISHED GOODS INVENTORY" (FGI) ON 2/8/96 AND WAS SHIPPED ON 2/21/97. THE "DOCUMENT CHANGE NOTICE" WHICH INSTRUCTED THE APPLICATION OF THE EXTRA LABELS DID NOT REQUIRE REWORK OF ANY PRODUCT ALREADY IN FGI. THE EXTRA LABELS THAT ARE NOW INCLUDED ARE VERIFIED IN THE BOXING AREA, THUS THIS DEVICE HAD ALREADY GONE THROUGH THIS PROCESS.

    Description of Event or Problem · 1

    THERE WERE NO STICKERS IN THE PACKAGE. THERE WAS NOT A PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IROX Implant PACEMAKER LEAD DTB SULZER INTERMEDICS INC. 430-07 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *