BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1001928 · Received February 15, 2008

    Report

    Report Number
    1028232-2008-00052
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    May 3, 2007
    Report Date
    January 18, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR AN ANALYSIS. THUS, THE ANALYSIS IS BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE MANUFACTURING DOCUMENTATION SHOWED NO ANOMALIES THAT COULD BE RELEVANT TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR. A DISLODGE WAS REPORTED AFTER AN IMPLANTATION TIME OF 2 MONTHS. A NEW LEAD WAS IMPLANTED.

    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 YR Hospitalization