BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZY PACING LEAD

    MDR report key: 2041460 · Received March 10, 2011

    Report

    Report Number
    1035166-2011-00008
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 6, 2011
    Report Date
    March 8, 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 CAPPED, WITH NO ADVERSE PATIENT EFFECTS REPORTED. AS A RESULT, THE LEAD WILL NOT BE RETURNED FOR ANALYSIS AND THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. 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 LEAD WAS CAPPED ON (B)(6), 2011. THE VENTRICULAR LEAD HAD HIGH LEAD IMPEDANCE READINGS (NO MEASUREMENTS WERE PROVIDED TO THE CUSTOMER). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 8 YEARS, 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR, INC. ZY 44 RJUSBV 4T7

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR