BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 2080445 · Received April 22, 2011

    Report

    Report Number
    3005168196-2011-00181
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 30, 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: INFARCTION AND EDEMA ARE ASSOCIATED WITH THE PROGRESSION OF STROKE DISEASE. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED COMPLICATION OF THE DISEASE. THE INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A (B)(6) (RETROSTART). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    PT WAS TREATED ON (B)(6), 2010 AND F/U CT SCANS ON (B)(6), 2010 REVEALED A MEDIA INFARCTION WITH LOW GRADE SPACE OCCUPYING EFFECT. THIS EVENT WAS REPORTED BY THE SITE TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE. MANNITOL WAS PROPHYLACTICALLY GIVEN TO PREVENT EDEMA. THE EVENT WAS NOT SERIOUS AND RESOLVED (B)(6), 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other