ARGUS II RETINAL PROSTHESIS 011014-001M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for ARGUS II RETINAL PROSTHESIS 011014-001M manufactured by Second Sight Medical Products, Inc..

Event Text Entries

[125917076] An argus ii retinal chip was implanted in the retina by dr (b)(6) in (b)(6) 2015. I was one of the very few who noticed positive results initially; see media reports, etc. The chip malfunctioned in the summer of 2018. There was no connection between the argus glasses and the chip. Dr (b)(6) and two staff from second sight have offered me no explanation as to why the malfunction occurred. This is not a one-off situation; made studies online report this finding. The tragedy is life altering. Equally important, nobody to my knowledge who has had the argus surgery in (b)(6) reports positive results. I have done my best to connect with as many such pts as possible. This product's functionality (short and long-term) needs to be carefully investigated. Second sight cannot offer a definite explanation as to what caused the malfunction. The company has little experience with implants that have been in as long as mine. Many recipients are elderly and have not voiced complaints; i am in the process of rounding several up so many complaints can be filed with health (b)(6). The only option offered to date has been explantation. This begs the question of what happens in another few years. Prior to surgery, i was assured all subsequent software updates would be handled remotely. One can only begin to imagine how frustrated a such as myself pt is. It seems there is a three or five year warranty; even this has been controversial. Dr (b)(6) was not aware of any warranty until this past summer. Neither my partner nor i were made aware of a warranty prior to surgery. Had we known of such, there would have been no surgery. The company's president and ceo claims the test period for approval, etc. Was five years. This is a prosthesis that precludes one from having mri's etc. I have yet to encounter anyone who is satisfied with the performance of argus ii. Previous tax dollars and funding from the foundation fighting blindness made possible this surgery. It's essential this product's longevity be investigated thoroughly before anyone else is subjected to argus ii.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080944
• MDR Report Key: 8023655
• Date Received: 2018-10-30
• Date of Report: 2018-10-26
• Date of Event: 2018-07-18
• Date Added to Maude: 2018-10-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ARGUS II RETINAL PROSTHESIS
• Generic Name: PROSTHESIS, RETINAL
• Product Code: NBF
• Date Received: 2018-10-30
• Model Number: ARGUS II
• Catalog Number: 011014-001M
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SECOND SIGHT MEDICAL PRODUCTS, INC.
• Manufacturer Address: 12744 SAN FERNANDO RD STE 400 SYLMAR CA 91342 US 91342

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-10-30