N
Patient 1
ALL PERTINENT INFORMATION AVAILABLE TO SECOND SIGHT MEDICAL PRODUCTS, INC. HAS BEEN SUBMITTED.
MAUDE MDR 7687002
- MDR report key
- 7687002
- Report number
- 3004081696-2018-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-25
- Date received
- 2018-07-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DR. PUNITA CHRISTOPHER, PHD
- Address
- 12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US
- Phone
- 818-818-8188
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARGUS II RETINAL PROSTHESIS | RETINAL PROSTHESIS | SECOND SIGHT MEDICAL PRODUCTS, INC. | NBF | 011016-002-K | 011016 | N/A | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-07-13 | 0 | 1. O |
Event Narratives#
D
Patient 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.