BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE FIX MRI

    MDR report key: 3973737 · Received August 1, 2014

    Report

    Report Number
    2649622-2014-07679
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    June 21, 2014
    Report Date
    November 8, 2024
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    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# 5086MRI52 A PROXIMAL PORTION WAS RECEIVED MEASURING 14 CM. BUT ANALYSIS COULD NOT BE PERFORMED DUE TO LEGAL RESTRICTIONS.

    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).

    Additional Manufacturer Narrative · 1

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

    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
    450234 CAPSURE FIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death A2DR01 IPG, 5086 LEAD| A2DR01 IPG, 5086 LEAD