BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 2895997 · Received November 19, 2012

    Report

    Report Number
    1028232-2012-02995
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    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 MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS. APPROX FIVE MONTHS AGO, PACING IMPEDANCE MEASUREMENTS WERE AROUND 600 OHMS. PACING IMPEDANCE MEASUREMENTS INCREASED TO 1,740 OHMS APPROX TWO WEEKS AGO. THRESHOLD AND SENSING MEASUREMENTS WERE STABLE. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE LEAD WHEN THE POCKET WAS OPENED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED. THIS LEAD IS NOT EXPECTED FOR RETURN AS IT WAS SURGICALLY ABANDONED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    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