BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 793565 · Received November 29, 2006

    Report

    Report Number
    6000078-2006-00575
    Event Type
    Malfunction
    Date Received
    November 29, 2006
    Date of Event
    November 6, 2006
    Report Date
    November 6, 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: PMA/510(K): H020002/S5. THE DEVICE IN QUESTION HAS BEEN RETURNED TO THE MANUFACTURER AND IS CURRENTLY IN PROCESS OF EVALUATION. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONFIRM THE USER'S COMPLAINT AND CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 11/06/2006 A PRODUCT PROBLEM OCCURRED DURING A ANEURYSM INTERVENTION OPERATION OF A VERTEBRAL ARTERY. IT WAS REPORTED THAT "WHEN BEFORE THE PROCEDURE, THE DOCTOR FIND THAT THE STENT 4.0 X 2.0 (DEVICE IN QUESTION) WAS BROKEN." IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, THAT THAT PATIENT HAD NO SERIOUS INJURY AND THAT THE PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION E340020 9024361

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR