BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4833595 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11191
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 IMPLANTABLE PULSE GENERATOR (IPG) UNDERWENT AN ELECTRICAL RESET. NO CHANGES TO PARAMETERS WERE NOTED BUT COUNTERS WERE CLEARED AND AN ELECTRICAL RESET ALERT MESSAGE WAS TRIGGERED. 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
    374845 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention 5086MRI52 LEAD, 5086MRI58 LEAD