BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PACING LEAD

    MDR report key: 2791566 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03359
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC PERFORATION AND CARDIAC TAMPONADE. FOLLOW UP INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE CURRENT LEAD DISPOSITION IS NOT KNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O SESR01 IMPLANTABLE PULSE GENERATOR