BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2446137 · Received February 6, 2012

    Report

    Report Number
    1028232-2012-00207
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 24, 2012
    Manufacturer
    BIOTRONIK, INC.
    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 THIS 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 RIGHT ATRIAL (RA) LEAD EXHIBITED NO SENSING, HOWEVER, IMPEDANCE AND THRESHOLD MEASUREMENTS WERE OBSERVED TO BE WITHIN AN ACCEPTABLE RANGE. AN ELECTIVE PROCEDURE WAS PERFORMED. THE POCKET WAS OPENED AND THE LEAD WAS INSPECTED AND NO ANOMALIES WERE OBSERVED. NO ADVERSE PT EFFECTS WERE REPORTED. AVAILABLE INFO INDICATES THAT THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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, INC. 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization