BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2780291 · Received October 10, 2012

    Report

    Report Number
    2182208-2012-03161
    Event Type
    Injury
    Date Received
    October 10, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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 ATRIAL LEAD WAS "NOT ABLE TO PACE" AT ANY OUTPUT, AND HAD A HIGH IMPEDANCE; THE LEAD WAS "SENSING WELL." AT THE TIME THE DEVICE WAS CHANGED OUT, DUE TO THE ATRIAL LEAD ISSUES, PER THE PHYSICIAN'S DECISION, THE LEAD REMAINS IN USE FOR SENSING PURPOSES ONLY. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R 4968 X2 IMPLANTABLE PACING LEADS| 8042 IMPLANTABLE PULSE GENERATOR