BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1864720 · Received October 5, 2010

    Report

    Report Number
    1028232-2010-02028
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 27, 2010
    Report Date
    September 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 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, ABOUT THREE WEEKS AGO, THIS PT FELL DOWN SOME STAIRS. FOLLOWING THIS EVENT, THIS DEXTRUS ATRIAL LEAD WAS EXHIBITING CAPTURE ONLY AT MAXIMUM DEVICE OUTPUTS AND P-WAVE MEASUREMENTS HAD DECREASED. THE PHYSICIAN ALSO SUSPECTED THAT THIS LEAD WAS ORIGINALLY IMPLANTED ON AN INFARCTED AREA OF HEART, POSSIBLY CONTRIBUTING TO THE REPORTED CLINICAL OBSERVATIONS AND SUSPECTED DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFO IS RECEIVED.

    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