BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2033172 · Received February 28, 2011

    Report

    Report Number
    1028232-2011-00450
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFO THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD HAS ELEVATED PACING THRESHOLDS. IT IS INTENDED TO REPLACE THIS LEAD IN THE FUTURE AND UPGRADE THIS PT TO A BIVENTRICULAR SYSTEM. THIS PT IS PACEMAKER DEPENDANT. CURRENTLY THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PT EFFECTS REPORTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    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 Other