BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 60

    MDR report key: 1012611 · Received March 10, 2008

    Report

    Report Number
    1028232-2008-00212
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 19, 2007
    Report Date
    February 8, 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 THUS BASED ON EXTANT PRODUCTION DOCUMENTS. THE PRODUCTION PROCESS WAS VERIFIED FOR THIS DEVICE. THE PRODUCTION DOCUMENTS SHOWED NOTHING UNUSUAL THAT COULD BE ASSOCIATED WITH THIS COMPLAINT. ALL PRODUCTION STEPS WERE CORRECTLY EXECUTED. IN SUMMARY, THERE IS NO INDICATION OF A MFG DEFECT.

    Description of Event or Problem · 1

    OUS MDR. ELEVATED PACING THRESHOLDS AND DISLODGED OF THE RV LEAD WERE REPORTED AFTER AN IMPLANT PERIOD OF APPROX 78 DAYS. THE LEAD WAS 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