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 2016-05-19 for ARGUS II RETINAL PROSTHESIS 011014-001-K 011014 manufactured by Second Sight Medical Products, Inc..
[45570537]
We do not believe that this event meets the definition of an mdr reportable event since: it did not involve a device that caused death or serious injury (while the event did lead to an explant which is a surgical intervention, the explant was not deemed medically necessary by the surgeon); nor did it involve a device that has malfunctioned. However, since the event did involve the explant of the argus ii due to patient-reported symptoms, we are reporting this event out of an abundance of caution. There is no defect or malfunction of the device associated with this event. All pertinent information available to second sight medical products 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
[45570538]
Patient (b)(6) was implanted with the argus ii device on (b)(6) 2012. This patient reported experiencing headaches and eye pain for the past several months. The doctors ordered a psychological evaluation since this patient only experienced headaches just prior to appointments related to the argus ii device. The patient elected to have the device removed and did not want to be seen by a psychologist. On (b)(6) 2016, the patient was explanted and the argus ii device was removed without any complication. On (b)(6) 2016, the patient was seen for a follow-up visit during which it was reported that the patient was doing well and was not experiencing pain anymore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2016-00006 |
| MDR Report Key | 5667613 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2016-05-19 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2012-05-09 |
| Date Added to Maude | 2016-05-19 |
| 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 | 2016-05-19 |
| Returned To Mfg | 2016-04-25 |
| Model Number | 011014-001-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2014-05-09 |
| 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 | 2016-05-19 |