BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1080878 · Received June 20, 2008

    Report

    Report Number
    2953200-2008-00453
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    March 6, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (LACK OF INFORMATION). CONCLUSIONS: (LACK OF INFORMATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. NO FURTHER INFO HAS BEEN OBTAINED. (MFR REPORT# 2953200-2008-00452).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000590383

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN