MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-04-21 for ARGUS II RETINAL PROSTHESIS 011013-003-K 011013 manufactured by Second Sight Medical Products, Inc..
[73385006]
Patient Sequence No: 1, Text Type: N, H10
[73385007]
Patient (b)(6) was implanted with an argus ii device on (b)(6) 2014, and was later explanted and re-implanted with another argus ii device during the same procedure on (b)(6) 2015. On (b)(6) 2017, the patient was diagnosed with conjunctival erosion and a retinal detachment. On (b)(6) 2017, revision surgery was performed during which the implant was covered with a bovine pericardium patch graft, and the conjunctiva was closed. The surgeon reported that the retinal detachment was stable and did not require surgical intervention. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2017-00007 |
| MDR Report Key | 6511914 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-04-21 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-24 |
| Device Manufacturer Date | 2014-12-21 |
| Date Added to Maude | 2017-04-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK LOAR |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8188335049 |
| Manufacturer G1 | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2017-04-21 |
| Model Number | 011013-003-K |
| Catalog Number | 011013 |
| Lot Number | N/A |
| Device Expiration Date | 2016-12-21 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-04-21 |