BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2961659 · Received February 14, 2013

    Report

    Report Number
    9612164-2013-00177
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE CX. DURING THE PROCEDURE THE STENT STRUTS BECAME FLARED. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64967 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006129848

    Patients

    Seq Age Sex Outcome Treatment
    1