BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENEX MRI

    MDR report key: 18581480 · Received January 25, 2024

    Report

    Report Number
    2017865-2024-02016
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 10, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ABBOTT
    Product Code
    LWP
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF PREMATURE DISCHARGE OF BATTERY WAS NOT CONFIRMED. THE DEVICE WAS RECEIVED WITH NORMAL OUTPUT AND TELEMETRY COMMUNICATION. ANALYSIS OF THE DEVICE IMAGE INDICATED FALSE ELECTIVE REPLACEMENT INDICATOR (ERI)/END OF SERVICE (EOS) ALERTS WERE TRIGGERED RELATED TO MULTIPLE MRI EVENTS. ELECTRICAL AND MECHANICAL TESTS PERFORMED INCLUDING OUTPUT VERIFICATION DID NOT IDENTIFY ANY FUNCTIONAL ISSUES. THE FALSE ERI/EOS ALERTS CAN BE CLEARED BY DOING A FIRMWARE RELOAD. DESPITE EXTENSIVE EFFORTS, THE REPORTED EVENTS COULD NOT BE REPRODUCED. LONGEVITY ASSESSMENT FOUND THE DEVICE WAS OPERATING AT NEAR BEGINNING-OF-LIFE VOLTAGE WITH APPROPRIATE REMAINING LONGEVITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE REACHED ERI. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND CONFIRMED THAT THE ERI ALERT WAS FALSE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888771 ZENEX MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ABBOTT PM2282 P000148064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention