BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 4071740 · Received August 27, 2014

    Report

    Report Number
    1028232-2014-03013
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    OUS MDR - SOMETIMES THE LEAD IMPEDANCE WAS ABOVE 3000 OHM, ACCORDING TO STATISTICS AND MEASUREMENTS PERFORMED MANUALLY. DURING THE DEVICE REPLACEMENT, THE PHYSICIAN WAS UNABLE TO PERFORM ELECTRICAL TESTS DUE TO THE AMOUNT OF NOISE FROM THE LV LEAD. THIS LEAD WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521425 COROX OTW-L 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization