BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PACING LEAD

    MDR report key: 3190969 · Received June 19, 2013

    Report

    Report Number
    1035166-2013-00013
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 18, 2013
    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) AND A NEW LEAD WAS IMPLANTED. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO BECOMES AVAILABLE. 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) 2013, THE CUSTOMER REPORTED THEIR SALES REP REPORTED THAT THIS LEAD HAD AN IMPEDANCE OF LESS THAN 200 OHMS. THEREFORE, IT WAS CAPPED AND REPLACED WITH A NEW LEAD. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 3 YEARS, 1.5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279238 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. PETITE 58 RU 10011191

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR