BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4135

    MDR report key: 1770345 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01515
    Event Type
    Other
    Date Received
    July 19, 2010
    Date of Event
    May 25, 2010
    Report Date
    July 1, 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 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. DISLODGEMENT WITH NO INTERVENTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT FOLLOWING IMPLANT OF THIS PACING SYSTEM, THIS ATRIAL DEXTRUS LEAD WAS EXHIBITING DECREASED P-WAVE MEASUREMENTS WITH SOME OVERSENSING AND NO CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED. 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 Other