BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2802992 · Received October 24, 2012

    Report

    Report Number
    2029214-2012-00568
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    April 14, 2012
    Report Date
    September 27, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION FROM INTREPED REGISTRY FROM CLINICAL DATABASE. TREATMENT OF AN ANEURYSM. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD AN ABRUPT ONSET HEADACHE (HA) WHICH WAS FOLLOWED BY NUMBNESS AND WEAKNESS. THESE ISSUES SUBSEQUENTLY RESOLVED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71425-25 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability