BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOS DR

    MDR report key: 627663 · Received August 16, 2005

    Report

    Report Number
    1028232-2005-00108
    Event Type
    Other
    Date Received
    August 16, 2005
    Report Date
    August 16, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE RETURNED IN BAG WITH 4 OTHER DEVICES. LEAD FRAGMENTS STILL ATTACHED TO DEVICE. INFO REC'D 08/10/2005. DEVICE RETURNED IN BAG WITH 4 OTHER DEVICES. LEAD FRAGMENTS STILL ATTACHED TO DEVICE. NO OOS DOCU7MENTATION REC'D.

    Description of Event or Problem · 1

    INFORMATION RECEIVED 08/2005. DEVICE RETURNED IN BAG WITH 4 OTHER DEVICES. LEAD FRAGMENTS STILL ATTACHED TO DEVICE. NO OOS DOCUMENTATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO. 338845 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other