BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4135

    MDR report key: 2100345 · Received May 12, 2011

    Report

    Report Number
    1028232-2011-01022
    Event Type
    Other
    Date Received
    May 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 3, 2011
    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 RECEIVED INFO THAT THIS ATRIAL LEAD WAS FOUND TO BE DISLODGED ONE DAY POST VALVE REPLACEMENT SURGERY. THIS WAS CONFIRMED VIA CHEST X-RAY. THIS ATRIAL LEAD ALSO EXHIBITED LOSS OF CAPTURE AS A RESULT. THIS LEAD WILL BE REPOSITIONED. AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    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 Other