BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1944399 · Received December 16, 2010

    Report

    Report Number
    1028232-2010-02710
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    October 8, 2010
    Report Date
    December 6, 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 PRODUCT 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 CRM RECEIVED INFORMATION THAT SEVERAL HOURS POST IMPLANT OF THIS DEXTRUS RIGHT VENTRICULAR LEAD, PACING PAUSES WERE OBSERVED. THE PAUSES WERE REPRODUCIBLE DURING MOVEMENT OF THE PATIENT AND THE PATIENT WAS SYMPTOMATIC, BUT NOT SYNCOPAL. A LEAD REVISION WAS PERFORMED AT WHICH TIME IT WAS NOTED THAT THE LEAD WAS NOT COMPLETELY ATTACHED TO THE SEPTAL WALL. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization