BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2882933 · Received December 21, 2012

    Report

    Report Number
    9612164-2012-01822
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    MALFUNCTION OF A RESOLUTE INTEGRITY STENT WAS REPORTED TO HAVE BEEN NOTED DURING A LIVE CASE DEMO AT A (B)(4) CONFERENCE. THE MALFUNCTION WAS REPORTED TO BE A STENT DEFORMATION EVENT. NO PATIENT INJURY OR NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1