BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2062998 · Received April 11, 2011

    Report

    Report Number
    1028232-2011-00821
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BIOTRONIK SE AND CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE AND POOR R WAVE MEASUREMENTS IN BOTH CONFIGURATIONS. AT THE LAST FOLLOW-UP VISIT, THE LEAD HAD BEEN PROGRAMMED TO UNIPOLAR CONFIGURATION SINCE THE R WAVE MEASUREMENTS WERE BETTER IN THIS CONFIGURATION. THE NOISE RESULTED IN VENTRICULAR TACHYCARDIA EPISODES AND WAS RECREATED WITH ISOMETRICS IN UNIPOLAR CONFIGURATION. THE NOISE COULD NOT BE RECREATED IN BIPOLAR CONFIGURATION. THE IMPEDANCE MEASUREMENTS CHANGED AFTER IMPLANT BUT HAVE BEEN STABLE OVER THE LAST YEAR, AS HAVE THE THRESHOLD MEASUREMENT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization