BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8959824 · Received September 4, 2019

    Report

    Report Number
    9612164-2019-03742
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PRE IMPLANT PREPARATION ATTEMPTS WERE CARRIED OUT. THE STENT WAS NOT IMPLANTED. CORRECTION TO PMA # P110013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED AND THAT THE STENT WOULD NOT INFLATE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756350 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009476643

    Patients

    Seq Age Sex Outcome Treatment
    1