BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6165664 · Received December 12, 2016

    Report

    Report Number
    9612164-2016-01288
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    December 3, 2014
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE RESOLUTE INTEGRITY STENT WAS IMPLANTED INTO THE LAD. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT DIED. DEATH WAS NON SUDDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817192 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007022494

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death