BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX SR 45

    MDR report key: 583420 · Received August 11, 2005

    Report

    Report Number
    1028232-2005-00104
    Event Type
    Injury
    Date Received
    August 11, 2005
    Date of Event
    May 13, 2005
    Report Date
    August 10, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED INFORMATION IN 08/2005. EVENT REPORT RECEIVED FROM SCIENTIFIC STUDIES: ATRIAL AND VENTRICULAR LEADS DISLODGE. DEVICE MIGRATING IN POCKET. BOTH LEADS REVISED SUCCESSFULLY IN 2005.

    Description of Event or Problem · 1

    RECEIVED INFO ON 8/2/2005. EVENT REPORT RECEIVED FROM SCIENTIFIC STUDIES: ATRIAL AND VENTRICULAR LEADS DISLODGED. DEVICE MIGRATING IN POCKET. BOTH LEADS REVISED SUCCESSFULLY IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 45 PACEMAKER LEAD DTB BIOTRONIK GMBH AND CO., 343081 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R