MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-13 for ARGUS II RETINAL PROSTHESIS 011016-002-K 011016 manufactured by Second Sight Medical Products, Inc..
[114035778]
All pertinent information available to second sight medical products, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[114035779]
This patient was implanted with the argus ii device on (b)(6) 2018. On (b)(6) 2018, it was reported that link with the implant could not be established.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004081696-2018-00008 |
MDR Report Key | 7687002 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2018-07-13 |
Date of Report | 2019-01-25 |
Date of Event | 2019-01-25 |
Date Mfgr Received | 2019-01-25 |
Device Manufacturer Date | 2018-01-03 |
Date Added to Maude | 2018-07-13 |
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 | DR. PUNITA CHRISTOPHER, PHD |
Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
Manufacturer City | SYLMAR CA 91342 |
Manufacturer Country | US |
Manufacturer Postal | 91342 |
Manufacturer Phone | 8188334119 |
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 | 2018-07-13 |
Returned To Mfg | 2019-02-06 |
Model Number | 011016-002-K |
Catalog Number | 011016 |
Lot Number | N/A |
Device Expiration Date | 2020-01-03 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
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. Other | 2018-07-13 |