BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230837 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01036
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ROOT CAUSE OF EVENT CANNOT BE DETERMINED; (REACTION); (NO DEVICE RECEIVED FOR EVALUATION).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO TREAT A LESION TO THE MID RIGHT CORONARY ARTERY. THE PHYSICIAN IMPLANTED TWO ENDEAVOR SPRINT STENTS SUCCESSFULLY. APPROX THREE MONTHS POST PROCEDURE A DRUG ERUPTION WAS OBSERVED IN THE PT. PALE ERYTHEMA WAS THE SYMPTOM AND THIS WAS TREATED USING A STEROID. THERE WAS NO PT INJURY REPORTED AND THE PT IS RECOVERING. INVESTIGATOR STATED IT IS UNK IF THE EVENT IF RELATED TO THE DEVICE. REFERENCE MFR REPORT NUMBERS 9612164201101035 AND 9612164201101036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CLOPIDOGREL| ASPIRIN