BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1941919 · Received December 23, 2010

    Report

    Report Number
    1028232-2010-02838
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    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 ONE DAY POST IMPLANT, THE RIGHT ATRIAL (RA) LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THE LEAD WAS NOT FULLY INSERTED IN TO THE DEVICE HEADER. THE RA LEAD WAS REINSERTED AND YIELDED GOOD MEASUREMENTS. BOTH THE DEVICE AND LEAD REMAIN IMPLANTED IN THE PT. NO ADVERSE PT EFFECTS WERE REPORTED AND THE INVESTIGATION IS COMPLETE AT THIS TIME. AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFO BECOMES 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 Hospitalization