BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 793615 · Received November 30, 2006

    Report

    Report Number
    6000078-2006-00573
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 5, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    h020002/s4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    G5: ALL MANUFACTURERS: PMA/510(K): H020002/S5. THE DEVICE IN QUESTIN WILL NOT BE RETURNED TO THE MANFACTURER FOR FURTHER INVESTIGATION AS IT WAS IMPLANTED INTO THE PATIENT. AN INVESTIGATION ON THE LOT HISTORY REVIEW OF THE DEVICE IN QUESTION IS CURRENTLY IN PROGRESS. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) ON 11/05/2006 THAT A CUSTOMER HAD PROBLEMS DURING USE OF A STENT. ACCORDING TO THE CUSTOMER: "...THE STENT (DEVICE IN QUESTION) RELEASED AHEAD OF SCHEDULE." NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NEUROFORM 3: STENT NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION E340020 8491602

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR