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 2017-03-09 for ARGUS II RETINAL PROSTHESIS 011014-007-K 011014 manufactured by Second Sight Medical Products, Inc..
[69524706]
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
[69524707]
This patient was implanted with an argus ii device on (b)(6) 2015 as part of a clinical trial for amd subjects. On (b)(6) 2019, the patient was diagnosed with ocular inflammation and a small conjunctival dehiscence in the implanted eye. The patient was prescribed steroids and antibiotics. On (b)(6) 2017, revision surgery was conducted during which the patient underwent an anterior chamber fluid tap and was given intracameral vancomycin and ceftazidime injections. Conjunctival suturing was performed as well. On (b)(6) 2017, the conjunctiva was re-sutured, and subconjunctival antibiotics and steroids were injected. On (b)(6) 2017, the culture tested positive, indicating endophthalmitis. On (b)(6) 2017, the patient underwent a third revision surgery during which a tutoplast patch was placed over the scleral patch, and the conjunctiva was re-sutured around the suture tab. Air was injected into the anterior chamber to prevent silicone oil (previously administered during an intervention) from entering. On (b)(6) 2017, the conjunctival and scleral patch were found to be well covered and secure. Intraocular pressure (iop) in the implanted eye was 6 mmhg. On (b)(6) 2017, the surgeon reported that patient had no active endophthalmitis, no cable exposure, and the conjunctiva was healing. The iop in the implanted eye was 4-6 mmhg. The patient continues to be on antibiotics and steroids. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[74185742]
This event represents a follow-up report to mdr# 3004081696-2017-00005. 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
[74185743]
This patient experienced ocular inflammation, endophthalmitis, hypotony, and conjunctival dehiscence in the implanted eye, and underwent three revision surgeries on (b)(6) 2017, respectively. New information: on (b)(6) 2017, conjunctival dehiscence along with low intraocular pressure (2-4 mmhg) was again observed in the implanted eye. There was no sign of infection and the retina was attached. On (b)(6) 2017, the patient underwent partial explant surgery whereby the extraocular portion of the device was removed and the electrode cable was cut extraocularly leaving the electrode array tacked to the retina. The sclerotomy was sutured closed. Patient was seen for follow-up visits on (b)(6) 2017, the endophthalmitis was considered resolved. On (b)(6) 2017, the eye appeared quiet, retina was attached, and the conjunctiva appeared to be healing. Iop was 2-4 mmhg in the implanted eye. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[96517046]
This event represents a second follow-up report to mdr# 3004081696-2017-00005. 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
[96517047]
This patient was implanted with an argus ii device on (b)(6) 2015 as part of a clinical trial for amd subjects. This patient experienced ocular inflammation, endophthalmitis, hypotony, and conjunctival dehiscence in the implanted eye, and underwent three revision surgeries on (b)(6) 2017, respectively. On (b)(6) 2017, the patient underwent a partial explant surgery whereby the extraocular portion of the device was removed and the electrode cable was cut extraocularly leaving the electrode array tacked to the retina. New information: on (b)(6) 2017, a retinal detachment was observed. No intervention has been scheduled at this time. On (b)(6) 2017, the intraocular pressure in the implanted eye was 0 mmhg. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2017-00005 |
| MDR Report Key | 6392932 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2014-11-06 |
| Date Added to Maude | 2017-03-09 |
| 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 | 2017-03-09 |
| Returned To Mfg | 2017-03-31 |
| Model Number | 011014-007-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2016-11-06 |
| Operator | PHYSICIAN |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2017-03-09 |