BEUDAMED
    FDA Adverse Event Summary report: N

    SETROX S 53

    MDR report key: 1213626 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01282
    Date Received
    October 24, 2008
    Date of Event
    May 5, 2008
    Report Date
    September 26, 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

    OUS MDR. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE PRODUCTION PROCESS OF THIS DEVICE WAS CHECKED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED 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 LETTER, SENT TO BIOTRONIK, FROM 2008, IT WAS REPORTED THAT THE RA LEAD WAS DISLODGED AFTER AN IMPLANTATION TIME OF ABOUT 6 DAYS. NO MACROSCOPIC ANOMALIES COULD BE SEEN AT THE LEAD. THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 NONE DTB BIOTRONIK, GMBH AND CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization