BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 4090350 · Received September 15, 2014

    Report

    Report Number
    2182208-2014-02486
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE ATRIAL HIGH RATE DETAIL, THE STORED LOW AMPLITUDE ATRIAL ELECTROGRAM MAKES IT DIFFICULT TO DETERMINE WHAT IS OCCURRING WITH THE PATIENT¿S RHYTHM. THE CLINICIAN HAD ATTEMPTED TO INCREASE THE GAIN OF THE ELECTROGRAM BUT WAS UNABLE TO. THE REAL-TIME ATRIAL ELECTROGRAMS DO NOT HAVE THE SAME ISSUE. IT WAS FURTHER REPORTED THERE WAS POSSIBLE FARFIELD OVERSENSING. THE DEVICE AND LEAD REMAIN 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
    568963 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR ADSR01 IPG