BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3860884 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10497
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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 DEVICE OVERSENSING RESULTED IN DROPPED PACED BEATS BEING OBSERVED POST OPERATIVELY. 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
    342992 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR 5086MRI X 2 IMPLANTABLE PACING LEADS