BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PACING LEAD

    MDR report key: 2010257 · Received February 11, 2011

    Report

    Report Number
    1035166-2011-00005
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 9, 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) AND A NEW LEAD WAS IMPLANTED WITH NO ADVERSE PT EFFECTS REPORTED, 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 INFO BECOMES AVAILABLE. NO ALLEGATION, OUR LEAD FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LEAD FRACTURE 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 LEAD WAS CAPPED DUE TO A FRACTURE AND A NEW LEAD WAS IMPLANTED WITH NO ADVERSE PT EFFECTS REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 1 YEAR, 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. PETITE52RB 4A2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR