BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PACING LEAD

    MDR report key: 4081079 · Received August 27, 2014

    Report

    Report Number
    1035166-2014-00054
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 26, 2014
    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 CAPPED, THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO BECOMES AVAILABLE. NO ALLEGATION OUR LEAD FAILED TO MEET ITS PERFORMANCE SPECS 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

    ON (B)(6) 2014, THE CUSTOMER REPORTED ACCORDING TO THEIR SALES REP, THIS LEAD WAS CAPPED ON (B)(6) 2014 DUE TO FRACTURE. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 7 YEARS, 9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518910 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. PETITE 58 RB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR