BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3860136 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10632
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 16, 2013
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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 THE PATIENT HAS AN ISSUE WHEN EXERCISING THAT THEIR HEART RATE WILL DROP AND AT TIMES IS FEELING SYMPTOMATIC. THE PATIENT BELIEVES THE RATE RESPONSE OF THEIR DEVICE IS NOT WORKING PROPERLY. THE PATIENT WAS SEEN AT THE CLINIC AND THE DEVICE SETTINGS WERE ADJUSTED. 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
    337048 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention (B)(4) LEAD , (B)(4) LEAD