BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 2565640 · Received May 4, 2012

    Report

    Report Number
    1028232-2012-01146
    Event Type
    Injury
    Date Received
    May 4, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 25, 2012
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DTB
    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 AND REPLACED DUE TO DISLODGEMENT. THE NOTES STATE THAT THE PT HAD LEFT SHOULDER SURGERY WHICH IS BELIEVED TO HAVE CAUSED THE DISLODGEMENT. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT. THE HOSPITAL RETAINED THIS DEVICE. SHOULD ADD¿L INFO BECOME AVAILABLE THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD DTB BIOTRONIK, INC. 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization