BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3083107 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01191
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 16, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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 INFORMATION THAT THE DAY AFTER AN EPICARDIAL IMPLANT, THIS RIGHT ATRIAL LEAD HAD NO AS MARKERS ON THE ELECTROGRAM (EGM). THE CAPTURE THRESHOLD WAS GOOD AT 0.6V AND THE IMPEDANCES WERE FINE. THE PATIENT WAS 100% ATRIAL PACED WITH RATES DOWN TO 30PPM, AND AAI PACING CONDUCTED THROUGH TO THE VENTRICLE. THE ATRIAL EGM WAS A FLAT LINE AND BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT IT SOUNDED LIKE THE PATIENT HAD ATRIAL STANDSTILL. AN X-RAY WAS DONE AND THE LEAD DOES NOT APPEAR TO HAVE MOVED. ANOTHER EVALUATION WAS PERFORMED THE NEXT DAY AND THE SAME OBSERVATIONS WERE NOTED. TWO DAYS LATER AN ADDITIONAL CHECK WAS PERFORMED. THERE WAS NO ATRIAL PACING AND THE PATIENT WAS NO LONGER IN A JUNCTIONAL RHYTHM. IT WAS CONFIRMED BY AN ELECTROCARDIOGRAM THAT P-WAVES WERE PRESENT. SUBSEQUENTLY THE PATIENT UNDERWENT AN ATRIAL LEAD REVISION AND IS DOING WELL. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    185393 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization