BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3831799 · Received May 27, 2014

    Report

    Report Number
    9612164-2014-00542
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE COULD NOT BE IDENTIFIED). INHERENT RISK OF PROCEDURE (REACTION). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). EVALUATION CONCLUSIONS: (ROOT CAUSE COULD NOT BE IDENTIFIED). INHERENT RISK OF PROCEDURE (REACTION). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A RESOLUTE STENT WAS IMPLANTED AND AFTERWARDS THE PATIENT EXPERIENCED A RASH. PATIENT DOES NOT HAVE ANY KNOWN METAL ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311278 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1