BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PACING LEAD

    MDR report key: 2980183 · Received February 1, 2013

    Report

    Report Number
    1035166-2013-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 31, 2013
    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. NO ADVERSE PT EFFECTS WERE REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION 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 IT WAS REPORTED BY THEIR REPRESENTATIVE THAT THE LEAD WAS FRACTURED. THE LEAD WAS CAPPED ON (B)(6) 2012, AND REPLACED WITH A NEW OSCOR LEAD. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45485 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC PETITE 52 RB 9091085

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR