BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 2980123 · Received February 27, 2013

    Report

    Report Number
    9612164-2013-00214
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    November 17, 2012
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSION: INHERENT RISK OF PROCEDURE - (DEATH).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR DUG ELUTING STENT IMPLANTED IN THE RCA. IT IS REPORTED THAT THE PATIENT EXPIRED APPROX 58 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84399 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000294872

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death ASA