BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3905077 · Received July 1, 2014

    Report

    Report Number
    9612164-2014-00696
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A RESOLUTE INTEGRITY RX 3.50 X 38 MM DRUG ELUTING STENT WAS IMPLANTED IN THE PATIENT 2 DAYS PAST IT'S EXPIRATION DATE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384569 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006577567

    Patients

    Seq Age Sex Outcome Treatment
    1