BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1982709 · Received February 2, 2011

    Report

    Report Number
    1028232-2011-00229
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 18, 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 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 IMPLANTABLE RIGHT ATRIAL LEAD DISLODGED ONE DAY POST IMPLANT. THE POCKET WAS REOPENED AND THE LEAD WAS REVISED. SHORTLY AFTER THE REVISION, LOSS OF CAPTURE WAS OBSERVED. IT WAS DETERMINED THE LEAD HAD DISLODGED A SECOND TIME. THE LEAD WAS THEN EXPLANTED AND REPLACED WITH ANOTHER MFR'S DEVICE. NO ADVERSE PT EFFECTS WERE REPORTED. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization