BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 3050957 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05912
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THAT ABOUT TWO WEEKS AFTER DEVICE IMPLANT, THE PATIENT STATED THAT THEIR HEART WAS GOING TOO FAST WITH LITTLE PHYSICAL ACTIVITY. THE PATIENT ALSO REPORTED THAT THEY WERE SCHEDULED TO SEE THEIR PHYSICIAN FOR A PACEMAKER CHECK IN FIVE DAYS. 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
    152817 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention 5086 X2 IMPLANTABLE PACING LEADS