BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3002023 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00609
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    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 NOISE WHICH LEAD TO INAPPROPRIATE MODE SWITCHES. A LEAD SAFETY SWITCH WAS NOTED WHICH CHANGED THE LEAD CONFIGURATION FROM BIPOLAR TO UNIPOLAR. A REVIEW OF THE DAILY LOGBOOK NOTED THAT THERE WERE 2 DAYS WHICH SHOWED THE LEAD IMPEDANCE AT N/R. ISOMETRICS WERE PERFORMED WHICH FOUND NOISE AND OVERSENSING, ALL OTHER MEASUREMENTS WERE WITHIN NORMAL RANGES. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONSULTED AND SUGGESTED DOING A CHEST X-RAY TO DETERMINE IF THE LEAD HAD MOVED AT ALL. AT THIS TIME, THE LEAD REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN 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
    105791 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Other