BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 4802414 · Received May 28, 2015

    Report

    Report Number
    1028232-2015-01758
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 24, 2015
    Report Date
    May 18, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ATRIAL TACHY RESPONSE, NOISY RIGHT ATRIAL LEAD ELECTROGRAM'S WERE OBSERVED. UPON REVIEW, THE SIGNALS ON THE RA CHANNEL WERE THOUGHT TO BE A RESULT OF NOISE; HOWEVER, IT ALSO APPEARED THAT THE PATIENT ENDURED ATRIAL FLUTTER. A FLAT EGM WITH LOSS OF CAPTURE WAS OBSERVED, HOWEVER, VENTRICULAR PACING MARKERS WERE PRESENT. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347365 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other