BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 2860332 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02737
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT ON (B)(6) 2012. THE LEAD REMAINS ACTIVELY IMPLANTED. THERE WERE NO ADVERSE PT EVENTS REPORTED. SHOULD ADDITIONAL INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    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 57 YR