BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1991582 · Received February 7, 2011

    Report

    Report Number
    1028232-2011-00208
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 27, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    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 THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED AND WAS FOUND TO HAVE DRIFTED INTO THE VENTRICLE. ON THE ELECTROCARDIOGRAM PRINT OUT, IT WAS DIFFICULT FOR THE MEDICAL PERSONNEL TO DETERMINE WHETHER RETROGRADE ACTIVITY OR LOSS OF CAPTURE HAD OCCURRED. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT PLANNED TO REVIEW AND PROVIDE INPUT. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM BEYOND THE NEED FOR SURGICAL INTERVENTION. TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WOULD BE FURTHER EVALUATED AND UPDATED. UNTIL SUCH TIME, THE INVESTIGATION IS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other