BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3853761 · Received June 6, 2014

    Report

    Report Number
    1028232-2014-01887
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 PATIENT HAD BEEN LOST TO FOLLOW UP FOR OVER TWO YEARS. THE PATIENT PRESENTED WITH SYNCOPE AND A VERY SLOW UNDERLYING RHYTHM. SYSTEM EVALUATION NOTED LOSS OF CAPTURE, VARYING PACING IMPEDANCE MEASUREMENTS WITH SOME OUT OF RANGE MEASUREMENTS THAT WERE LESS THAN 200 OHMS. ADDITIONALLY, THERE WAS NOISE WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION AND GREATER THAN TWO SECONDS OF ASYSTOLE FOR THIS PATIENT. THE PHYSICIAN SUSPECTED PROBABLE INSULATION DAMAGE TO THIS RIGHT VENTRICULAR (RV) DEXTRUS LEAD. THE DEVICE WAS PROGRAMMED TO DOO MODE AND THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE. THE FOLLOWING DAY, THE RV LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. THE DEVICE REMAINS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331943 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization