BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1901279 · Received November 9, 2010

    Report

    Report Number
    1028232-2010-02395
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 18, 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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE SENSING ON THE RIGHT VENTRICULAR LEAD DECREASED FROM 7MV TO 1.6MV. IT WAS NOTED THAT THE PHYSICIAN STUCK THE VEIN MORE MEDIAL THAN USUAL, RESULTING IN THE LEAD HAVING A BEND AT THE ACCESS POINT. THIS LEAD MICRO-DISLODGED. THEREFORE, THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PT EFFECTS WERE REPORTED. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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