MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-22 for ARGUS II RETINAL PROSTHESIS 011014-002-K 011014 manufactured by Second Sight Medical Products, Inc..
[50291469]
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
[50291470]
Patient (b)(6) was implanted with the argus ii device on (b)(6) 2014. This patient reported experiencing visual percepts in both eyes that were maroon in color with the device turned on and off, although it was reduced in the implanted eye with the device on. The surgeon believes that her symptoms were not device-related and that she was suffering from charles bonnet syndrome. Patient nonetheless elected to have the device explanted. On (b)(6) 2016, the argus ii device was surgically explanted without any adverse sequelae. Following explantation, the patient reported that she is no longer experiencing previously reported visual symptoms.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004081696-2016-00010 |
MDR Report Key | 5817652 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2016-07-22 |
Date of Report | 2016-06-23 |
Date of Event | 2016-06-23 |
Date Mfgr Received | 2016-06-23 |
Device Manufacturer Date | 2014-01-26 |
Date Added to Maude | 2016-07-22 |
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 | 2016-07-22 |
Returned To Mfg | 2016-06-27 |
Model Number | 011014-002-K |
Catalog Number | 011014 |
Lot Number | N/A |
Device Expiration Date | 2016-01-26 |
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. Required No Informationntervention | 2016-07-22 |