BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS II RETINAL PROSTHESIS

    MDR report key: 7687002 · Received July 13, 2018

    Report

    Report Number
    3004081696-2018-00008
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    January 25, 2019
    Report Date
    January 25, 2019
    Manufacturer
    SECOND SIGHT MEDICAL PRODUCTS, INC.
    Product Code
    NBF
    PMA / PMN Number
    H110002
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2018. ON 7/5/18, IT WAS REPORTED THAT LINK WITH THE IMPLANT COULD NOT BE ESTABLISHED. NEW INFORMATION: ON (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR A SURGICAL INTERVENTION ON (B)(6) 2019 TO EXPLANT THE DEVICE AND RE-IMPLANT A NEW DEVICE IN THE SAME EYE.

    Description of Event or Problem · 0

    THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2018. ON (B)(6) 2018, IT WAS REPORTED THAT LINK WITH THE IMPLANT COULD NOT BE ESTABLISHED. NEW INFORMATION: THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2019 DURING WHICH THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS RE-IMPLANTED IN THE SAME EYE. ON (B)(6) 2019, THE SURGEON REPORTED THAT THE PATIENT WAS DOING WELL.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO SECOND SIGHT MEDICAL PRODUCTS, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THIS PATIENT WAS IMPLANTED WITH THE ARGUS II DEVICE ON (B)(6) 2018. 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
    526497 ARGUS II RETINAL PROSTHESIS RETINAL PROSTHESIS NBF SECOND SIGHT MEDICAL PRODUCTS, INC. 011016-002-K N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other