BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 2220047 · Received July 13, 2011

    Report

    Report Number
    1028232-2011-01556
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    June 11, 2011
    Manufacturer
    BIOTRONIK SE & CO., KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED (B)(6) 2011, DUE TO A HIGH THRESHOLDS. A COMPETITIVE LEAD WAS THEN IMPLANTED, WHICH RESULTED IN A PERFORATION. THE PT THEN EXPIRED HOURS POST-PROCEDURE. NO ADD'L INFO IS AVAILABLE AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT 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 61 YR Hospitalization