BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2833055 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02750
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 25, 2012
    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 RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. THE LEAD HAD DISLODGED THE SAME DAY OF IMPLANT POST POCKET CLOSURE. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD. REPOSITIONING WAS UNSUCCESSFUL AND THE LEAD WAS EXPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization