BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO SURESCAN PACEMAKER

    MDR report key: 2830322 · Received November 7, 2012

    Report

    Report Number
    MW5027568
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH MRI-CONDITIONAL PACEMAKER WAS HAVING A MRI BRAIN EXAM. THE SPECIFIC PROTOCOL RECOMMENDED BY MEDTRONIC WAS INITIATED. THE MEDTRONIC REP EVALUATED THE PACER DEVICE AND PROGRAMMED THE DEVICE TO MRI-CONDITIONAL SCANNING PARAMETERS. THE PT WAS MONITORED THROUGHOUT THE EXAM WITH THE CARDIOLOGY FELLOW PRESENT. TOWARD END OF EXAM, PT REPORTED A SHARP ELECTRIC SHOCK EXTENDING UP HER RIGHT NECK AND FACE. PT WAS IMMEDIATELY REMOVED FROM THE MRI SCANNER AND EVALUATED BY CARDIOLOGY FELLOW. MEDTRONIC REP EVALUATED DEVICE AND FOUND IT FULLY FUNCTIONAL. PT REMAINED HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVO SURESCAN PACEMAKER REVO SURESCAN PACEMAKER LWP MEDTRONIC RVDR01
    2 REVO SURESCAN PACEMAKER REVO SURESCAN PACEMAKER LWP MEDTRONIC 5086MRI52
    3 REVO SURESCAN PACEMAKER REVO SURESCAN PACEMAKER LWP MEDTRONIC 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other