BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 1902850 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02385
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 22, 2010
    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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS LEAD WAS IMPLANTED AND WHEN TESTING THROUGH THE PSA, MEASUREMENTS WERE EXCELLENT. POST IMPLANT, THE LEAD IMPEDANCES WERE LESS THAN 100 OHMS AND THERE WAS NO CAPTURE OR SENSING. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED.

    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 Hospitalization