BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 7461769 · Received April 25, 2018

    Report

    Report Number
    2182208-2018-00747
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 25, 2018
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE THE PATIENT WAS BEING PACED WITH THE ANALYZER THE PATIENT BECAME PACING-DEPENDENT AND THE ANALYZER GENERATED A MESSAGE "EITHER RESTART OR END SESSION." A TEMPORARY PULSE GENERATOR WAS USED. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN SERIAL NUMBER AND DISPOSITION INFORMATION ON THE ANALYZER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED VIA FOLLOW-UP THAT WHILE PACE MAPPING FOR LEAD PLACEMENT THE ANALYZER CHANGED ITS RATE WITHOUT ANY COMMAND AND BEGAN PACING AT 30 BEATS-PER-MINUTE(BPM) FROM 130 AND GENERATED THE "RESTART OR END SESSION" MESSAGE. THE RATE WAS REPROGRAMMED TO 130 BPM AND A COMPETITOR'S EXTERNAL PULSE GENERATOR (EPG) WAS ALSO EMPLOYED TO USE AS BACK-UP. THE ANALYZER AGAIN DROPPED ITS RATE TO 30 BPM AND THE GENERATED "RESTART" MESSAGE RECURRED AND IN ADDITION THE ANALYZER FAILED TO CAPTURE AND THE PATIENT WENT ASYSTOLIC. PACING WAS BEGUN WITH THE EPG AND SIMULTANEOUSLY THE HOSPITAL ELECTROPHYSIOLOGY TECHNICIAN CAME ON PACING THROUGH THE MAPPING SYSTEM. BOTH WERE SLAVED INTO THE HIS LEAD BLOCK FOR SIGNALS BUT SINCE THE MAPPING SYSTEM COULD ONLY PACE AND NOT TEST THE POTENTIAL LEAD IT WAS PULLED AND ONLY KEPT AS BACK-UP AND THE CASE PROCEEDED. THE PATIENT SUSTAINED A FEW PAUSES DURING THE EVENT, WITH THE LONGEST MEASURED AT 8 - 9 SECONDS. NEITHER THE ANALYZER NOR THE LEAD HAVE BEEN RECEIVED INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303033 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R