BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 2961502 · Received February 14, 2013

    Report

    Report Number
    9612164-2013-00174
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): EVALUATION, RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (IFU INSTRUCTS THE USER TO USE THE PRODUCT BEFORE ITS UBD). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED AN INTEGRITY STENT IN A PATIENT IN AN EMERGENCY PROCEDURE. THE PRODUCT WAS USED ONE DAY BEYOND ITS USE BY DATE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66092 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0005367908

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR