BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATOS LV

    MDR report key: 1770166 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01507
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    October 22, 2009
    Report Date
    June 29, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER (B) (4) ADVERSE EVENT REPORT, THIS PT DEVELOPED A "BASEBALL SIZED" HEMATOMA POST DEVICE IMPLANT. THE HEMATOMA WAS SUCCESSFULLY DRAINED ON (B) (6)2009, AND THE SYSTEM REMAINS IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS REPORT WILL BE UPDATED. SETROX S 45, (B) (4), MDR 1028232-2010-01508; COROX OTW-S 75-BP, (B) (4), MDR 1028232-2010-01509; SETROX S 45, (B) (4), MDR 1028232-2010-01510.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATOS LV PACEMAKER NVZ BIOTRONIK SE & CO. KG 338200

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization