MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-04 for ARGUS II RETINAL PROSTHESIS 011014-003-K 011014 manufactured by Second Sight Medical Products, Inc..
[81904355]
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, the explant was not deemed medically necessary by the surgeon. 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 due to a patient-reported system. 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
[81904356]
This patient was implanted with an argus ii device on (b)(6) 2016. Patient reported experiencing pain in the implanted eye for the past few weeks. Patient canceled all scheduled visual rehabilitation appointments and refused to be seen at the implanting center in (b)(6). Patient elected to have the device removed at a non-certified center in (b)(6), against the recommendation of the argus ii surgeon, who made several efforts to convince the patient to be seen at the clinic in (b)(6) or at any other argus ii implanting center. On (b)(6) 2017, prof. (b)(6) in (b)(6) reported that 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 | 3004081696-2017-00008 |
| MDR Report Key | 6769067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-04 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2015-03-13 |
| Date Added to Maude | 2017-08-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2017-08-04 |
| Model Number | 011014-003-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2017-03-13 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2017-08-04 |