BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3001937 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00603
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    June 1, 2012
    Report Date
    February 27, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND PACEMAKER DISPLAYED WHAT LOOKED TO BE EITHER LOSS OF VENTRICULAR CAPTURE OR NOISE LEADING TO STORED EPISODES. THE PATIENT WAS BEING SEEN FOR ROUTINE FOLLOW UP WHEN THIS WAS DISCOVERED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT PACE IMPEDANCES WERE GOOD AND WITHIN NORMAL RANGE. SOME R-WAVE MEASUREMENTS WERE REPORTED TO HAVE BEEN IN THE 2 MILLIVOLT RANGE. THE REPRESENTATIVE PERFORMED ISOMETRICS AND POCKET MANIPULATION AND NO NOISE WAS PRODUCED. THE PHYSICIAN ELECTED TO PROGRAM SENSITIVITY TO A FIXED NUMBER AT 2.5 MILLIVOLTS. THERE WERE NO ADVERSE PATIENT EFFECTS. THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105097 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other