BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY

    MDR report key: 2915203 · Received December 20, 2012

    Report

    Report Number
    2915203
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 16, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO DELIVER STENT TO IN-STENT RE-STENOSIS LESION IN EXISTING STENT. ON REMOVAL FROM PATIENT, STENT WAS FOUND TO BE UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC * 006029943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR