BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PACING LEAD

    MDR report key: 4231689 · Received October 14, 2014

    Report

    Report Number
    1035166-2014-00063
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 10, 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. 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 BASED ON INFO RECEIVED FROM THEIR SALES REP, THIS PT'S LEAD WAS CAPPED ON (B)(6) 2014 DUE TO HIGH IMPEDANCE. NO SUBSEQUENT DEVICE OR CLINICAL ADVERSE EVENTS HAVE BEEN REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 1 YEAR, 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648761 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. ELAPASS P 758 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR