BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2901643 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03464
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 19, 2012
    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

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACE DUE TO A LEAD INSULATION ISSUE, CONDUCTOR FRACTURE, AND A LEAD DISLODGEMENT INTO THE VENTRICLE. THE PT WAS REPORTED TO HAVE TWIDDLER'S SYNDROME AND MAY HAVE CONTRIBUTED TO THE ISSUE. 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
    881 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358762

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization