BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 879826 · Received July 9, 2007

    Report

    Report Number
    6000078-2007-00191
    Event Type
    Malfunction
    Date Received
    July 9, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS AS IT WAS DISPOSED OF BY THE USER FACILITY. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. ADD'L PMA/510(K)# H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED INSIDE THE PATIENT DURING THE PROCEDURE AND JAMMED. IT WAS NOT DISCLOSED IF OR HOW THE STENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THE PATIENT SUFFERED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRAVASCULAR STENT NJE BOSTON SCIENTIFIC SNF33520 9535031

    Patients

    Seq Age Sex Outcome Treatment
    1 YR