BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2456340 · Received February 8, 2012

    Report

    Report Number
    1028232-2012-00256
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 30, 2012
    Manufacturer
    BIOTRONIK, INC.
    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 MFG. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD DISPLAYED AN INCREASE IN PACE IMPEDANCE FROM 500 OHMS TO 1600 OHMS. THE THRESHOLDS WERE MEASURED AT 2.4 V AND THE SENSING WAS MEASURED AT 1.5 MV. AS A RESULT ANOTHER PROCEDURE WAS PERFORMED TO REMOVE THE LEAD. THE LEAD WAS SUCCESSFULLY REMOVED AND ANOTHER RA LEAD WAS IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION IS COMPLETE. THIS INFO WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED. NO DATE OF EXPLANT WAS PROVIDED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK, INC. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization