BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2943954 · Received January 31, 2013

    Report

    Report Number
    1028232-2013-00137
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 18, 2013
    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 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 RECEIVED INFO THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS OF 3.0 V AT 1.0 MS, SO PACEMAKER OUTPUTS WERE PROGRAMMED TO 6.5 V AT 1.0 MS, AND SUBSEQUENTLY THE GENERATOR REACHED ELECTIVE REPLACEMENT TIME AFTER APPROX THREE YEARS OF SERVICE. SURGICAL INTERVENTION WAS PERFORMED. FLUOROSCOPIC EVAL WAS DONE ON THIS RV LEAD; THE LEAD APPEARED TO HAVE DISLODGED THEN REATTACHED HIGH ON THE SEPTAL WALL. THIS LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD AND PACEMAKER GENERATOR WERE IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42114 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization