BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3223717 · Received July 12, 2013

    Report

    Report Number
    9612164-2013-00710
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    February 7, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (CVA/STROKE). CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR DRUG-ELUTING STENT IMPLANTED IN THE LAD. APPROXIMATELY 57 MONTHS POSTTHE INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323955 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization ASPIRIN