BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3862412 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01692
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE-OUT PROCEDURE ON A PACEMAKER DEPENDENT PATIENT, THE PHYSICIAN CHANGED THE LEAD POLARITY BEFORE THE IMPLANT AND WHEN OLD DEVICE WAS READY FOR REPLACEMENT, IT WAS DISCONNECTED FROM THE LEAD AND THE NEW DEVICE WAS QUICKLY CONNECTED, BUT PACING FAILED. THE NEW DEVICE WAS DISCONNECTED FROM THE LEAD AND THE ORIGINAL OLD DEVICE WAS RE-CONNECTED AGAIN, BUT PACING WAS STILL NOT PRESENT. THE PHYSICIAN CONNECTED SURGICAL CABLE TO THE LEAD AND SUCCESSFUL PACING WAS RESTORED. ADRENALIN WAS ADMINISTRATED TO THE PATIENT AND AN INTRINSIC RHYTHM OF 70 BEATS PER MINUTE WAS OBSERVED. THE NEW DEVICE WAS CONNECTED AGAIN AND WHEN THE RHYTHM SLOWED BELOW THE PROGRAMMED LOWER RATE THE DEVICE STARTED TO PACE. THE PHYSICIAN TRIED TO INTERROGATE THE DEVICE WITH TWO DIFFERENT PROGRAMMERS, BUT TELEMETRY FAILED. A SECOND REPLACEMENT DEVICE WAS PROGRAMMED TO BIPOLAR CONFIGURATION AND CONNECTED TO THE LEAD. PACING WAS PRESENT IMMEDIATELY, BUT NO TELEMETRY WAS ESTABLISHED. IT WAS NOTED DURING THE PROCEDURE THE ELECTROCAUTERY WAS IN PASSIVE MODE. AT THIS POINT THE ELECTROCAUTERY AND X-RAY WERE TURNED OFF AND TELEMETRY WAS RESTORED. THE SECOND REPLACEMENT DEVICE WAS IMPLANTED AND REMAINS IN USE. THE PROGRAMMERS 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
    338538 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R