BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY2 PACING LEAD

    MDR report key: 3173229 · Received June 7, 2013

    Report

    Report Number
    1035166-2013-00011
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 6, 2013
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THRESHOLD ELEVATION 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

    ON (B)(6) 2013, THE CUSTOMER REPORTED THIS ATRIAL LEAD WAS EXPLANTED AND DISCARDED DUE TO HIGH THRESHOLDS (7 VOLTS); THE PHYSICIAN EXTRACTED LEAD(S) AND CHOOSE TO CHANGE OUT DEVICE DUE TO DRAIN ON BATTERY. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 1 YEAR, 7 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253535 PY2 PACING LEAD RETRACTABLE SCREW - IN PACING LEAD DTB OSCOR INC. PY2 44 RU 11041526

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR