BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 4833815 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02004
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 4, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE EMERGENCY VVI PACING WAS INADVERTENTLY ACTIVATED BY THE PEN GETTING TOO CLOSE TO THE COUCH SCREEN. SUBSEQUENTLY, THERE WAS POCKET STIMULATION AROUND THE PACER IMPLANT SITE AND PECTORAL DISCOMFORT. THE DEVICE WAS PROGRAMMED BACK TO THE PRIOR SETTINGS. THE PROGRAMMER 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
    375222 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention