BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1013147 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00342
    Event Type
    Injury
    Date Received
    March 12, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER OOS AND PT TRACKING, THIS SYSTEM WAS REMOVED DUE TO INFECTION. WHEN FCS WAS CALLED TO COME SEE PT, SHE NOTED PT HAD NO SYSTEM IMPLANTED. SHE ASSISTED WITH THE IMPLANTING OF A NEW SYSTEM IN 2007. REP WAS ASKED FOR CLARIFICATION AND SHE STATED TO PT TRACKING THAT THE SYSTEM HAD BEEN REMOVED DUE TO INFECTION, BUT THAT SHE HAD NOT BEEN INFORMED OF THE COMPLAINT UNTIL AFTER IT WAS EXPLANTED. THERE IS NO EXPLANT DATE AVAILABLE. ALSO REMOVED: CYLOS DR-T, MDR 1028232-2008-00242; SETROX S 60, MDR 1028232-2008-00343.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization