BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 822487 · Received February 26, 2007

    Report

    Report Number
    1028232-2007-00032
    Event Type
    Injury
    Date Received
    February 26, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 2, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LEAD WAS REMOVED AND REPLACED AFTER DISLODGEMENT DUE TO THE PT TWIDDLING THE ICD. EXPLANTED LEADS WERE DISCARDED. THE LV LEAD AND THE ICD WERE RE-USED AND NOT EXPLANTED. ALSO REMOVED: LINOX SD 65/18, MDR 1028232-07-0031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350973 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization