BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3801625 · Received May 9, 2014

    Report

    Report Number
    9612164-2014-00503
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS/CONCLUSIONS: RECOMMENDED THAT SHELF LIFE BE VERIFIED PRIOR TO USE. DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW. EXPIRED PRODUCT IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A RESOLUTE INTEGRITY OTW 2.50 X 18 MM DRUG ELUTING STENT WAS IMPLANTED APPROXIMATELY 4 DAYS POST ITS EXPIRATION DATE. NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280678 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006511780

    Patients

    Seq Age Sex Outcome Treatment
    1