BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1853614 · Received September 28, 2010

    Report

    Report Number
    1035166-2010-00053
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 28, 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), THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE REPORTED ALLEGATION CANNOT BE CONFIRMED. THE LEAD WAS SUCCESSFULLY REPLACED AND TO DATE, THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION 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 PT WAS EXHIBITING OVERSENSING WHICH LED TO PACING INHIBITION OF GREATER THAN 2 SECONDS. LOW IMPEDANCE MEASUREMENTS OF 240 OHMS WERE NOTED, AS WELL AS AN INSULATION BREAK IN THE LEAD. THE LEAD WAS SURGICALLY ABANDONED (CAPPED ON (B)(6), 2010) AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PT EFFECTS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4018 4T8

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR