BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 484480 · Received September 17, 2003

    Report

    Report Number
    2182863-2003-00043
    Event Type
    Injury
    Date Received
    September 17, 2003
    Date of Event
    August 26, 2003
    Report Date
    September 17, 2003
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 28 MONTHS OF IMPLANTATION, IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP INTERROGATION THAT THERE WAS NO ATRIAL CAPTURE POSSIBLE. IN ADDITION, THERE WAS INTERMITTENT ATRIAL SENSING. NOTE: ELA MEDICAL, INC. WAS NOTIFIED OF THIS CASE IN 2003 AND AT THAT TIME THE DEVICE WAS RE-PROGRAMMED AND REMAINED IMPLANTED. HOWEVER, 3 WEEKS LATER THE PACEMAKER WAS EXPLANTED BECAUSE OF HIGH ATRIAL LEAD IMPEDANCE AND LOSS OF CAPTURE IN BOTH UNIPOLAR AND BIPOLAR AS WELL AS MARGINAL ATRIAL LEAD SENSING. IT WAS REPORTED TO CO THAT THE ATRIAL SET-SCREW WAS LOOSE. THE SET-SCREW WAS TIGHTENED AND TESTING SHOWED NORMAL LEAD IMPEDANCE IN BIPOLAR, BUT REMAINED HIGH IN UNIPOLAR. IT WAS ALSO REPORTED THAT WHEN THE PHYSICIAN PERFORMED THE UNIPOLAR TESTING, THE DEVICE WAS OUTSIDE OF THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 213 S010130

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R