BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY2 PACING LEAD

    MDR report key: 2123483 · Received June 7, 2011

    Report

    Report Number
    1035166-2011-00018
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    April 13, 2011
    Report Date
    June 2, 2011
    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 DISCARDED, 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 INFORMATION BECOMES AVAILABLE. BOTH THRESHOLD ELEVATION AND LEAD DISLODGEMENT ARE RECOGNIZED CLINICAL EVENTS 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 LEAD WAS EXPLANTED (DISCARDED) 2 DAYS AFTER IMPLANT DUE TO HIGH THRESHOLDS (MEASUREMENTS NOT KNOWN) AND DISLODGEMENT. A NEW TINED LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED." THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY2 PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY2 58 RU 10061297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR