BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 6248794 · Received January 13, 2017

    Report

    Report Number
    9612164-2017-00045
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    November 21, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED INTO THE R-PAV VESSEL. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED FROM A HEMORRHAGE - STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33469 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization