BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3111012 · Received May 14, 2013

    Report

    Report Number
    9612164-2013-00530
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT. IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI APPROXIMATELY 24 MONTHS POST THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213238 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002513079

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization