BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3160339 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10105
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED OF FATIGUE AND HEART RATE NOT INCREASING WHEN WALKING. FOLLOW UP WAS CONDUCTED WITH THE PHYSICIAN'S OFFICE AND IT WAS DISCLOSED THE PATIENT'S HEART RATE DID INCREASE WHILE WALKING. IT WAS ALSO NOTED THE LOWER RATE ON THE DEVICE WAS INCREASED. 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
    259759 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention 5086MRI X2 IMPLANTABLE PACING LEAD