BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2810833 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03703
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 4, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO THE DEVICE, P-WAVE SENSING MEASUREMENT WAS NOT POSSIBLE, EVEN THOUGH PATTERN WAS AS-VP (ATRIAL SENSE - VENTRICULAR PACE) IN DDD MODE. DURING IMPEDANCE MEASUREMENT, THERE WAS A FREEZE OF THE MENU (CURSOR COULD STILL BE MOVED, BUT OPTIONS WERE DISABLED) FOR MINUTES. THE PROGRAMMER WAS SWITCHED OFF AND WHEN IT WAS TRIED A SECOND TIME THE MENU FROZE AGAIN DURING IMPEDANCE MEASUREMENT. A DIFFERENT PROGRAMMER WAS USED. THE DEVICE REMAINS IN USE. 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 KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other