BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4112480 · Received September 24, 2014

    Report

    Report Number
    9612164-2014-01231
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    January 3, 2014
    Report Date
    December 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS - INHERENT RISK OF PROCEDURE (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE AN ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 52 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED A STROKE AND WAS HOSPITALISED. THE PATIENT WAS TREATED WITH MEDICATION AND RECOVERED WITHOUT SEQUELAE. THE INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE

    Description of Event or Problem · 1

    THE PATIENT IS REPORTED TO BE CONTINUING WITH TREATMENT AS A RESULT OF THE PREVIOUSLY REPORTED STROKE.

    Description of Event or Problem · 1

    THE PATIENT IS REPORTED TO BE CONTINUING WITH TREATMENT AS A RESULT OF THE PREVIOUSLY REPORTED STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593266 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R