BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3242385 · Received July 23, 2013

    Report

    Report Number
    9612164-2013-00731
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    February 1, 2013
    Report Date
    July 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (HAEMORRHAGE). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE LAD. IT IS REPORTED THAT APPROXIMATELY TEN DAYS LATER THE PATIENT SUFFERED RECTAL BLEEDING. THE PATIENT WAS TREATED WITH MEDICATION. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS REMOTELY RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342805 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006500743

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization CLOPIDOGREL AND ASPIRIN.