BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2892393 · Received December 18, 2012

    Report

    Report Number
    1028232-2012-03298
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 4, 2012
    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 INFORMATION THAT THIS PATIENT HAD SEVERE TRICUSPID REGURGITATION AND THIS RIGHT VENTRICULAR LEAD WAS PLACED ON THE APEX. THE LEAD WAS REPORTED TO HAVE HIGH THRESHOLDS AND IMPEDANCES (VALUES WERE NOT PROVIDED). IT WAS THOUGHT THAT THE LEAD HAD PERFORATED THE PATIENT'S ANATOMY PRIOR TO THE HELIX EXTENSION. THE LEAD WAS THEN REPOSITIONED CLOSE TO THE INITIAL POSITION AND UPON EXTENDING THE HELIX THE PATIENT'S BLOOD PRESSURE DROPPED ACUTELY. AN ECHOCARDIOGRAM WAS PERFORMED AND CARDIAC TAMPONADE WAS PRESENT. THE FLUID WAS IMMEDIATELY TAPPED AND THE PATIENT WAS STABILIZED. THE LEAD REMAINS IMPLANTED WITH STABLE LEAD VALUES. 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
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG. 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization