BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4137

    MDR report key: 1902698 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02523
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    September 27, 2010
    Report Date
    November 2, 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 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

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT PASSED AWAY. THE PT HAD EXPERIENCED A MYOCARDIAL INFARCTION (MI) EARLIER IN THE DAY. A BOSTON SCIENTIFIC REPRESENTATIVE STATED THAT THEY HAD IMPLANTED THE LEADS AND THEN THE PT WENT INTO VENTRICULAR FIBRILLATION (VF) AND DIED BEFORE THEY WERE ABLE TO COMPLETE THE IMPLANT. THE ASSOCIATED PACEMAKER WAS NEVER OPENED FOR IMPLANT, JUST THE LEADS. THERE ARE NO ALLEGATIONS AGAINST THE PRODUCT PERFORMANCE OF THE DEXTRUS LEADS. THE LEADS WERE SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFO IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death