BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1941853 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02846
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 13, 2010
    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

    PT COMPLAINED OF PAIN AROUND THE IMPLANT POCKET. THE PHYSICIAN PLANNED TO MOVE THE DEVICE TO THE OTHER SIDE. HOWEVER, DURING THE EXPLANT, THE PHYSICIAN QUESTIONED THE PT'S NEED FOR A DEVICE, AND THE WHOLE SYSTEM WAS REMOVED. THERE ARE NO COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE.

    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 39 YR Hospitalization