BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791493 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03288
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PROGRAMMER WOULD NOT INTERROGATE THE DEVICE. THE CLINICIAN TRIED ANOTHER PROGRAMMER AND WAS ABLE TO INTERROGATE THE DEVICE. THE COMPANY REPRESENTATIVE WAS ABLE TO INTERROGATE THE DEVICE WITH SAME PROGRAMMER. THE RADIOFREQUENCY HEAD (RF) WILL BE RETURNED AND REPLACED AS A PRECAUTIONARY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER RF HEAD KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other