BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2895995 · Received November 19, 2012

    Report

    Report Number
    1028232-2012-02983
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    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 ATRIAL LEAD EXHIBITED LOW P-WAVE AMPLITUDE AND DECREASED IMPEDANCE MEASUREMENTS. HOWEVER, PACING WAS STILL AVAILABLE. IT WAS REPORTED THAT THE LEAD IMPEDANCE SIGNIFICANTLY CHANGED IN LATE SPRING OF THIS YEAR WITH MEASUREMENTS OF APPROX 125 OHMS. SUBSEQUENTLY SURGICAL INTERVENTION WAS PERFORMED, AND UPON OPENING THE POCKET THE INSULATION WAS OBSERVED TO BE CIRCUMFERENTIALLY TORN NEAR THE DISTAL PIN. ALSO, IT HAD RETRACTED INTO THE TISSUE LEAVING THE COIL EXPOSED, BUT THE COIL LOOKED UNAFFECTED. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RA LEAD WAS IMPLANTED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. 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 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization