BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 2012559 · Received February 28, 2011

    Report

    Report Number
    1028232-2011-00466
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    November 23, 2010
    Report Date
    February 21, 2011
    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 IMPLANTED AND BECAME DISLODGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization