BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1910252 · Received November 22, 2010

    Report

    Report Number
    1028232-2010-02568
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    July 22, 2010
    Report Date
    November 9, 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 THIS OEM MFG TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. THE LEAD BECAME DISLODGED WHILE THE POCKET WAS OPEN DURING PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD), AND THE PHYSICIAN ELECTED TO REPLACE THE LEAD AT THAT TIME. NO ADVERSE PT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION.

    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