BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 2900001 · Received December 26, 2012

    Report

    Report Number
    1035166-2012-00031
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 19, 2012
    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

    THIS LEAD WAS SURGICALLY ABANDONED (CAPPED); 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

    THE CUSTOMER REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED FOR HIGH OUTPUTS AT 6.5 V AT 1 MS. THE LEAD EXHIBITED HIGH CAPTURE THRESHOLDS (NO VALUES GIVEN) AND LOW, OUT-OF-RANGE (OOR) IMPEDANCES OF 110 OHMS. SURGICAL INTERVENTION WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED (CAPPED). A NEW RV LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 10 YEARS, 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4017 2S12

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR