BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2942113 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03471
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 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 OUT OF RANGE IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS AND OVERSENSING WITH INHIBITION WERE OBSERVED WITH THIS DEVICE. PATIENT IS NOTED BEING PACEMAKER DEPENDENT, HOWEVER, NO ASYSTOLE OCCURED AS THE INHIBITION WAS FOR 1.5 SECONDS. THERE WERE NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCAL FIELD REPRESENTATIVE DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES THERE MAY BE INSULATION DAMAGE TO THE LEAD, BUT AT THIS TIME IS NOT CONFIRMED. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O