BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY¿

    MDR report key: 6089769 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-09935
    Event Type
    Death
    Date Received
    November 9, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, POST STENT IMPLANTATION, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739506 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK776

    Patients

    Seq Age Sex Outcome Treatment
    1 Death