BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 85-BP

    MDR report key: 2431362 · Received January 20, 2012

    Report

    Report Number
    1028232-2012-00098
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 21, 2011
    Manufacturer
    BIOTRONIK, INC.
    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 DISLODGED AND COULD NOT BE REPOSITIONED. THEREFORE, IT WAS EXPLANTED. THE HOSPITAL HAS RETAINED THIS DEVICE. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 85-BP LV LEAD NKE BIOTRONIK, INC. 354807

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization