BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2082808 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00956
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    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 THE PT HAS BEEN COMPLAINING OF A PAIN ON THE LEFT SIDE SINCE IMPLANT OF THE PACEMAKER SYSTEM. THE RIGHT VENTRICULAR LEAD HAS EXHIBITED A HIGH THRESHOLD MEASUREMENT OF 6.5 VOLTS AT 0.4 MS SINCE IMPLANT. CAPTURE WAS NOTED IN BIPOLAR CONFIGURATION, HOWEVER THERE WAS LOSS OF CAPTURE IN UNIPOLAR WHEN THRESHOLDS WERE SET TO 6.5 VOLTS AT 1.0 MS. IMPEDANCE MEASUREMENTS WERE STABLE AT 680 OHMS. THERE IS CONCERN OVER A POSSIBLE PERFORATION. NO ADDITIONAL ADVERSE PT 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
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other