BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1941813 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02810
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    October 28, 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 PT WITH THIS IMPLANTABLE PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXPERIENCED INCREASED PACING THRESHOLDS, DECREASE IN PACING IMPEDANCE AND DECREASE IN R-WAVE AMPLITUDE. THEREFORE, THE LEAD WAS REPOSITIONED DURING AN ABLATION PROCEDURE. FOLLOWING THE PROCEDURE, LOSS OF CAPTURE WAS OBSERVED WHEN THE PT ROLLED ONTO THEIR RIGHT SIDE. THEREFORE, ANOTHER REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED. DURING THE PROCEDURE BLOOD WAS OBSERVED EXITING THE DISTAL AND PROXIMAL SETSCREWS. THEREFORE, THE PACEMAKER WAS EXPLANTED ALSO. NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization