BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 3843143 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01821
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 21, 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 RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE DURING ROUTINE ATRIAL THRESHOLD TEST. IT WAS CONFIRMED THAT THE LEAD HAD MOVED FROM THE ORIGINAL IMPLANT POSITION. A REVISION PROCEDURE WAS PERFORMED WHEREIN THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND HAS MAINTAINED THE REVISED POSITION TO DATE. THE FIELD REPRESENTATIVE INDICATED THAT AT THE TIME THAT LOC WAS DISCOVERED THERE WAS NO REPORT OF NOISE OR OVERSENSING; HOWEVER, A REDUCED P-WAVE WAS OBSERVED AT 0.4 MILLISECONDS. ASYSTOLE GREATER THAN 2 SECONDS WAS NOT DETECTED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    321932 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization