BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 60

    MDR report key: 1120868 · Received August 15, 2008

    Report

    Report Number
    1028232-2008-00931
    Event Type
    Injury
    Date Received
    August 15, 2008
    Report Date
    July 23, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS IS BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DO 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 - IT WAS REPORTED THAT A MYOCARDIAL PERFORATION WITH PERICARDIAL HEMATOMA OCCURRED DURING THE POSITIONING OF THE LEAD. THE IMPLANTATION AND EXPLANTATION DATA WERE NOT AVAILABLE TO US. THE LEAD IS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 PACER LEAD DTB BIOTRONIK GMBH AND CO. 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization