BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELOX ST 60

    MDR report key: 649368 · Received December 2, 2005

    Report

    Report Number
    1028232-2005-00186
    Event Type
    Other
    Date Received
    December 2, 2005
    Date of Event
    August 24, 2005
    Report Date
    November 29, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED FROM TRANSLATION 10/25/2005. LEAD EXHIBITS EXIT AND ENTRANCE BLOCK INTRAOPERATIVELY, DURING THE MEASUREMENT WITH TWO MEASUREMENT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 LEAD LWS BIOTRONIK GMBH AND CO., 346367 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention