BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 2901656 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03456
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    January 29, 2011
    Report Date
    December 17, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    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

    DUE TO OVER USE OF THE LEFT ARM, THIS LEAD DISLODGED, WHICH RESULTED IN SEVERE BRADYCARDIA. BOTH LEADS WERE REPOSITIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization