BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC. PACEMAKER AZURE XT DR MRI SURE SCAN

    MDR report key: 11965912 · Received June 8, 2021

    Report

    Report Number
    MW5101771
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 6, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT VISIBLE FORCEFUL JOLTING FROM MY HUSBANDS PACEMAKER FOR AN UNK PERIOD IN THE EARLY AFTERNOON. HE HAD A HEADACHE, WEAKNESS AND EXHAUSTION. HE BEGAN TO TAKE A NAP BEFORE THE END OF EPISODE. EVENT OCCURRED FOR ABOUT TEN MINS BEFORE HE MOVED CLOSE TO HIS MONITORING DEVICE AS HE WAS GETTING A BANDAGE CHANGED. HEART RATE, BEGINNING ON (B)(6) 2021 WENT HIGHER FOR TWO DAYS. IT WENT FROM 62 TO 71 ON (B)(6) AND 72 ON (B)(6). HEART RATE POST NAP AFTER THE INCIDENT WAS 63 AND 64 THIS MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859498 MEDTRONIC, INC. PACEMAKER AZURE XT DR MRI SURE SCAN IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention