BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2573337 · Received April 27, 2012

    Report

    Report Number
    1028232-2012-01093
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    July 28, 2010
    Report Date
    April 13, 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

    THE PT WAS HAVING A TRICUSPID VALVE REPAIR AND THE PHYSICIAN CHOSE TO REPLACE THE SYSTEM AT THE SAME TIME. THE HOSPITAL RETAINED THESE DEVICES. SHOULD ADDITIONAL INFO BECOME AVAILABLE THIS FILE WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization