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 2017-09-13 for ARGUS II RETINAL PROSTHESIS 011014-003-K 011014 manufactured by Second Sight Medical Products, Inc..
[86080259]
Based on the information available, this event does not appear to meet the definition of an mdr reportable event for the following reasons: it is not associated with a device that caused death or serious injury. While the event did lead to removal of the device through surgical intervention, explantation was an elective decision made by the patient. It is not associated with a device that has malfunctioned. We are nonetheless reporting this event as it did involve the explant of the argus ii. 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.
Patient Sequence No: 1, Text Type: N, H10
[86080260]
This patient was implanted with an argus ii device on (b)(6) 2016. This patient reported experiencing discomfort and photopsia in the implanted eye for the past few months. The patient was prescribed pain management medication, eye drops for inflammation, topical steroids, hydration ointments, and was advised psychotherapy; however, the patient did not fully comply with the surgeon's recommendations. The patient continued to experience discomfort and photopsia. Patient elected to have the device removed as she felt that she was not receiving any benefit from the system. The argus ii device was explanted on (b)(6) 2017, without any complication. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2017-00014 |
| MDR Report Key | 6863535 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-09-13 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Device Manufacturer Date | 2015-03-13 |
| Date Added to Maude | 2017-09-13 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2017-09-13 |
| Returned To Mfg | 2017-08-22 |
| Model Number | 011014-003-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2017-03-13 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-13 |