BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 2080446 · Received April 22, 2011

    Report

    Report Number
    3005168196-2011-00150
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    September 21, 2010
    Report Date
    March 28, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A PENUMBRA (B)(4) (RETROSTART). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PT EXPERIENCED A VASOSPASM IN THE ICA WHICH WAS REPORTED BY THE SITE TO HAVE A PROBABLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE. THIS VASOSPASM WAS REPORTED AS SERIOUS AND SUCCESSFULLY TREATED WITH NEMOTROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention