BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2812280 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05989
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SINCE THE DEVICE WAS IMPLANTED "MY HEART RATE SEEMS TO GO FASTER AND FASTER" AND THAT "IT'S OVER 100 AND DOESN'T WANT TO SLOW DOWN." IT WAS LATER REPORTED BY THE PATIENT'S CLINIC THAT THE ATRIAL PREFERENCE PACING WAS PROGRAMMED OFF AS THIS WAS DETERMINED TO BE WHAT WAS CAUSING THE PATIENT'S INCREASED HEART RATE. THE DEVICE 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
    1 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR LWP MEDTRONIC MED REL, INC. RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5086MRI X2 IMPLANTABLE PACING LEADS