BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 2842080 · Received November 15, 2012

    Report

    Report Number
    1028232-2012-02875
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 30, 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

    WHILE SEWING UP THE POCKET, THE PHYSICIAN NOTICED THAT THIS LEAD HAD BECOME DISLODGED. THE POCKET WAS REOPENED AND THE PHYSICIAN REPOSITIONED THE LEAD; WHILE REPOSITIONING THE LEAD, THE PHYSICIAN NOTED THAT THE HELIX WAS STIFF. ONE DAY POST IMPLANTED, THIS LEAD WAS FOUND TO BE DISLODGED AGAIN. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD AGAIN; HOWEVER THE HELIX WAS STIFF AND DIFFICULT TO MOVE, SO THE PHYSICIAN REQUESTED A NEW LEAD. WHEN THE LEAD WAS REMOVED FROM THE BODY, THE PHYSICIAN NOTED THAT THERE WAS TISSUE ATTACHED TO THE TIP OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization