BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 1622413 · Received February 22, 2010

    Report

    Report Number
    1028232-2010-00151
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    September 17, 2009
    Report Date
    February 8, 2010
    Manufacturer
    BIOTRONIK FSE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    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 MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. 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 - NO CAPTURE WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 45 MONTHS. THE LEAD WAS NOT RETURNED TO BIOTRONIK. NO WORSENING OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE DATE OF THE EXPLANT WAS NOT PROVIDED, AND THERE WAS NO INFORMATION PROVIDED TO SUGGEST WHAT INTERVENTION WAS PROVIDED, IF ANY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other