BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3192586 · Received June 27, 2013

    Report

    Report Number
    9612164-2013-00672
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: SHELF LIFE EXCEEDED/NO DEVICE FAILURE - DEVICE USED BEYOND UBD; FAILURE TO FOLLOW INSTRUCTIONS-DEVICE USED BEYOND UBD. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED-DEVICE IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    THE RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED 1 DAY POST ITS USE BY DATE. PROCEDURE WAS COMPLETED AND PATIENT DISCHARGED WITHOUT INCIDENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292436 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005991847

    Patients

    Seq Age Sex Outcome Treatment
    1