BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 1811233 · Received August 11, 2010

    Report

    Report Number
    1035166-2010-00045
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 16, 2010
    Report Date
    August 11, 2010
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED (CAPPED, WITH NO ADVERSE PT EFFECTS REPORTED), THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE REPORTED ALLEGATION CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFO BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS RIGHT ATRIAL LEAD HAD A LOW BIPOLAR IMPEDANCE OR 140 OHMS AND THE CAPTURE THRESHOLD MEASUREMENT HAD RISEN TO 3.0 MV AT .5 MS. THE UNIPOLAR IMPEDANCE WAS 350 OHMS AND THE CAPTURE THRESHOLD MEASUREMENT WAS 1.8 MV AT .5 MS. THE SENSING WAS POOR IN BOTH CONFIGURATIONS, 1.0 MV. THE LEAD WAS ABANDONED SURGICALLY (CAPPED) AND REPLACED WITH ANOTHER MANUFACTURES LEAD. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 9 YEARS, 11 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY 52 PSBV 1Q6

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR