BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 1900081 · Received November 10, 2010

    Report

    Report Number
    1035166-2010-00061
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 10, 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. TO DATE, NO ADVERSE PT EFFECTS HAVE BEEN REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO BECOMES AVAILABLE. LEAD FRACTURE IS A RECOGNIZED CLINICAL EVENT REFERENCED IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. 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 ATRIAL LEAD WAS EXHIBITING HIGH IMPEDANCES AND THRESHOLD MEASUREMENTS. FLUOROSCOPY REVEALED THE LEAD WAS FRACTURED. THE PHYSICIAN BELIEVED THIS DAMAGE WAS DUE TO CLAVICULAR CRUSH. THE LEAD WAS SURGICALLY ABANDONED (CAPPED) AND REPLACED. TO DATE, NO ADVERSE PT EFFECTS HAVE BEEN REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 12 YEARS, 2 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 44 PSBV 1P5

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR