BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 74-BP

    MDR report key: 2394970 · Received December 22, 2011

    Report

    Report Number
    1028232-2011-03104
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    November 8, 2011
    Report Date
    December 13, 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 MALPOSITIONED AND A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND ALL RECORDS INDICATE THAT LEAD REMAINS ACTIVELY IMPLANTED. 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 74-BP LV LEAD NKE BIOTRONIK SE & CO. KG 354805

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization