BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGUS II RETINAL PROSTHESIS

    MDR report key: 7857782 · Received September 7, 2018

    Report

    Report Number
    3004081696-2018-00009
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 8, 2018
    Manufacturer
    SECOND SIGHT MEDICAL PRODUCTS, INC.
    Product Code
    NBF
    PMA / PMN Number
    H110002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO SECOND SIGHT MEDICAL PRODUCTS, INC. HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    PATIENT (B)(6) WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2015. ON (B)(6) 2018, IT WAS REPORTED THAT LINK WITH THE IMPLANT COULD NOT BE ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695949 ARGUS II RETINAL PROSTHESIS RETINAL PROSTHESIS NBF SECOND SIGHT MEDICAL PRODUCTS, INC. 011014-001-K N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR