BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2901662 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03525
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED DUE TO SUBCLAVIAN CRUSH. THE LEADS WERE RUBBING AGAINST EACH OTHER OVER TIME. THERE WERE NO ADVERSE PT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADD'L INFO BE REC'D, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization