BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2892059 · Received January 2, 2013

    Report

    Report Number
    9612164-2013-00002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 19, 2012
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THERE WAS ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE CX. IT IS REPORTED THAT THE PATIENT SUFFERED A STROKE APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001463402

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization CLOPIDOGREL AND ASPIRIN.