BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2964529 · Received February 15, 2013

    Report

    Report Number
    3002807561-2013-00002
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    July 19, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWP
    PMA / PMN Number
    PTN236345H
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THAT THE PATIENT HAS TAKEN THEIR HEART RATE WITH THREE DIFFERENT MONITORS AND IT WAS 44 BEATS PER MINUTE. THE DEVICE IS PROGRAMMED TO A RATE OF 60 BEATS PER MINUTE. PATIENT ALSO STATES THAT IT IS HARDER TO INCREASE HIS HEART RATE WITH EXERCISE. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67495 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR 5086 X 2 IMPLANTABLE PACING LEADS