BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1921899 · Received December 6, 2010

    Report

    Report Number
    1028232-2010-02685
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 26, 2010
    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT NOISE ON THE RIGHT ATRIAL (RA) LEAD WITH A POSSIBLE SET SCREW ISSUE WAS REPORTED. UPON DEVICE CHECK, THE NOISE ON THE RA WAS CONFIRMED. THE NOISE WAS INTERMITTENT, BUT REPRODUCABLE WITH POCKET MANIPULATION. ATRIAL IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS, BUT WOULD DECREASE TO MEASURE WITHIN ACCEPTABLE LIMITS. AN INVASIVE SURGICAL PROCEDURE WAS PERFORMED TO BETTER CONNECT THE RA LEAD WITH THE DEVICE. ONCE THE DEVICE WAS OUT OF THE POCKET, THE PHYSICIAN PULLED ON THE RA LEAD, WHICH WAS NOT LOOSE IN THE HEADER. HOWEVER, THE PHYSICIAN FELT THAT THE LEAD WAS NOT ALL THE WAY IN THE HEADER EVEN THOUGH, THE SET SCREW HAD CAPTURED THE LEAD TIP, THE LEAD RING WAS NOT IN CONSTANT CONTACT WITH THE RING LEAF SPRING. THE PHYSICIAN CHOSE TO KEEP THE EXISTING DEVICE. THE PT WENT HOME LATER THAT DAY WITH NO KNOWN ADVERSE EVENTS. ALL AVAILABLE INFO INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADD'L INFO AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    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 Hospitalization