BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISA MRI SURESCAN

    MDR report key: 3973730 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13842
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    June 21, 2014
    Report Date
    November 8, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    UDI-DI
    00613994713650
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# A2DR01. THE DEVICE WAS RETURNED BUT ANALYSIS COULD NOT BE PERFORMED DUE TO LEGAL RESTRICTIONS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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

    A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REPORTED AS DECEASED DUE TO A MOTOR VEHICLE ACCIDENT. THE SHERIFF INQUIRED IF THE IPG WAS WORKING AT THE TIME OF THE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449988 ADVISA MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01 00613994713650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death 5986 LEADS X2| 5986 LEADS X2