BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2893984 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03282
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 8, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    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

    OUS MDR - IT WAS REPORTED THAT AFTER AN IMPLANT DURATION OF ABOUT 2 WEEKS, DURING A FOLLOW-UP, LOSS OF CAPTURE AND A FIRST DEGREE HEART BLOCK WAS OBSERVED. PERICARDIAL EFFUSION WAS CONFIRMED AT THE HOSPITAL. IT WAS DECIDED TO PERFORM A LEAD REPOSITIONING PROCEDURE IN THE NEAR FUTURE. THIS RIGHT VENTRICULAR LEAD REMAINS IN SERVICE. THE LEAD WAS NOT RETURNED TO BIOTRONIK (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK SE & CO. KG 360312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other