BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4091189 · Received September 16, 2014

    Report

    Report Number
    9612164-2014-01201
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 2, 2013
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS IMPLANTED IN THE LCX. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A GI BLEED. PATIENT WAS TREATED WITH MEDICATION. PATIENT DISCHARGED WITH NO OTHER CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573744 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization CLOPIDOGREL AND ASPIRIN.