BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY SR

    MDR report key: 6923039 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01606
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    January 22, 2017
    Report Date
    July 20, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 66 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: MAGNETIC RESONANCE IMAGING IN NONDEPENDENT PACEMAKER PATIENTS WITH PACEMAKERS AND DEFIBRILLATORS WITH A NEARLY DEPLETED BATTERY. PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY. 2017; 40(5):476-481.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING A PATIENT RECEIVING MAGNETIC RESONANCE IMAGING (MRI) WITH AN IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE NOTED THE IPG EXPERIENCED A FULL POWER ON RESET (POR) AS A RESULT OF THE SCAN. ADDITIONALLY, THE DEVICE RETURNED TO DEFAULT PARAMETERS. THE IPG WAS REPROGRAMMED AND REMAINS 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
    699805 PRODIGY SR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 8158B

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention