BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3993683 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02299
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PACEMAKER REPLACEMENT, AT THE MOMENT THE PHYSICIAN DISCONNECTED THE LEAD FROM THE PACEMAKER, THE NURSE WHO WAS USING THE ANALYZER TOOK TOO MUCH TIME TO PROGRAM THE VOO MODE IN THE ANALYZER (NOT IN THE PACEMAKER). THE MEDICAL STAFF BELIEVES THAT THE NEW 2090X PROGRAMMER PEN IS NOT AS PRECISE AS THE PREVIOUS ONE. THIS PROBLEM CAUSED AN ASYSTOLE IN A PACEMAKER-DEPENDANT PATIENT. THE ISSUE WAS RESOLVED BY INSISTING PROGRAMMING THE VOO MODE. THE PROGRAMMER REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467173 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2290 PACING SYSTEM ANALYZER