BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3242417 · Received July 23, 2013

    Report

    Report Number
    9612164-2013-00736
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 3, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN AN UNKNOWN LOCATION. IT IS REPORTED THAT 26 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344307 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002492775

    Patients

    Seq Age Sex Outcome Treatment
    1