BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2200923 · Received June 30, 2011

    Report

    Report Number
    1028232-2011-01403
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BIOTRONIK SE & 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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR (RV) DEXTRUS LEAD HAD BEEN EXHIBITING DECREASING IMPEDANCE MEASUREMENTS DUE TO SUSPECTED INSULATION DAMAGE. THE OUT OF RANGE MEASUREMENTS TRIGGERED THE LEAD SAFETY SWITCH (LSS). ADDITIONALLY, DIAPHRAGMATIC STIMULATION WAS OBSERVED DUE TO THE UNIPOLAR PACING WAS BEING PROVIDED AFTER THE LSS HAD BEEN SET. A LEAD REVISION WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFO IS RECEIVED.

    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