BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 2072531 · Received April 19, 2011

    Report

    Report Number
    1035166-2011-00014
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 11, 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 SURGICALLY ABANDONED (CAPPED), THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. LEAD DISLODGEMENT 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 CHRONIC RIGHT ATRIAL (RA) LEAD HAD BECOME DISLODGED AND FELL INTO THE VENTRICULAR. THE LEAD WAS NOT ABLE TO BE REPOSITIONED. LEAD WAS EXPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 7 YEARS, 10 MONTHS. ON (B)(6), 2011, THE CUSTOMER UPDATED THEIR REPORT, STATING THE LEAD WAS SURGICALLY ABANDONED (CAPPED); NOT EXPLANTED AS ORIGINALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW - IN PACING LEAD DTB OSCOR INC. 4016 1T9

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR