BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW

    MDR report key: 3242302 · Received July 23, 2013

    Report

    Report Number
    9612164-2013-00735
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    February 20, 2013
    Report Date
    July 12, 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

    EVALUATION RESULTS AND CONCLUSIONS: (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN AN UNKNOWN LOCATION. IT IS REPORTED THAT APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342996 ENDEAVOR SPRINT OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000916030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization