BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 3992323 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02400
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: 4968-35 LEAD IMPLANTED: 2014-(B)(6); 4965-35 LEAD IMPLANTED: 2003-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RANDOM T-WAVE OVERSENSING WAS NOTED DURING IN-OFFICE EVALUATION. THE T-WAVE OVERSENSING WAS NOT REPRODUCIBLE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468269 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR C4TR01 IPG