BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 2883782 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02764
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BIOTRONIKSE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT'S LV LEAD WAS NOTED TO NOT BE CAPTURING DURING A ROUTINE FOLLOW-UP. THERAPY WAS DISABLED. ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS INACTIVELY IMPLANTED. THERE WERE NO ADVERSE PATIENT SIDE EFFECTS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 85-BP LV LEAD NKE BIOTRONIKSE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other