BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 1983219 · Received February 2, 2011

    Report

    Report Number
    1028232-2011-00251
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    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 WOULD NOT CAPTURE W/O PHRENIC STIMULATION. A REPOSITIONING PROCEDURE WAS ATTEMPTED, BUT THE PHYSICIAN WAS UNABLE TO FIND AN APPROPRIATE POSITION. THIS LEAD WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization