BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW 75-BP

    MDR report key: 1952643 · Received January 3, 2011

    Report

    Report Number
    1028232-2010-02891
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    August 25, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HIGH IMPEDANCE MEASUREMENTS AND NO CAPTURE AT MAX OUTPUTS WERE NOTED ON THIS LV LEAD. THE BIV PACING WAS DISABLED. ON (B)(6) 2010, THE PHYSICIAN ATTEMPTED TO REVISE THE LEAD, BUT WAS UNABLE TO OBTAIN ACCEPTABLE PACING PARAMETERS. THEREFORE, THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITIVE LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 354805

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization