BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1941843 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02812
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS SUCCESSFULLY REPOSITIONED. HOWEVER, THE LEAD DISLODGED AGAIN. DURING THE SECOND REVISION PROCEDURE THE LEAD WAS EXPLANTED AND A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED. IMPLANT AND EXPLANT DATES FOR THIS EVENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization