BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW 85-BP

    MDR report key: 2771424 · Received September 28, 2012

    Report

    Report Number
    1028232-2012-02484
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 17, 2012
    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

    THIS LEAD HAS OUT OF RANGE IMPEDANCES, WHICH ARE TOO HIGH. IT IS SUSPECTED THAT THE CONDUCTOR HAD FRACTURED. THE PHYSICIAN IS CONTINUING TO FOLLOW THIS LEAD AND IT IS STILL ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 354807

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other