BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC, INC.

    MDR report key: 2123407 · Received November 3, 2008

    Report

    Report Number
    2123407
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 31, 2008
    Product Code
    LWO
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, PATIENT UNDERWENT PLACEMENT OF SINGLE CHAMBER PERMANENT PACEMAKER. PER MD, VENDOR REPRESENTATIVE HANDED MD AN EXPIRED (7/08) PRODUCT WITHOUT CHECKING THE PACKAGING AND THE DEVICE WAS IMPLANTED. MD TO DISCLOSE INCIDENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. 52CM SINGLE CHAMBER PACEMAKER LWO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other IMPLANTED RIGHT ATRIUM