BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXXIM MEDICAL

    MDR report key: 528624 · Received June 4, 2004

    Report

    Report Number
    1625425-2004-00003
    Event Type
    Injury
    Date Received
    June 4, 2004
    Date of Event
    April 12, 2004
    Report Date
    May 10, 2004
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TEMPORARY PACER PLACED VIA SUBCLAVIAN IN 2004. THE NEXT DAY HAD A SYNCOPAL EPISODE IN BED. PACER WAS NOT CAPTURING. PERMANENT PACER PLACED THE SAME DAY. GREEN HUB HAD BEEN MISSING. REMOVED DURING PLACEMENT OF PACE-MAKER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL TRANSVENOUS PACER DYB MAXXIM MEDICAL 008566 UNK (POSSIBLY 99364213)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other