MAUDE Adverse Event Report: SECOND SIGHT MEDICAL PRODUCTS INC. ARGUS II RETINAL PROSTHESIS

Model Number 011014-001-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 09/08/2014

Event Type  Injury  

Event Description

This patient was implanted with the argus ii device on (b)(6) 2012.This patient is participating in a post-market study of the argus ii.On (b)(6) 2014, the patient presented with endophthalmitis in the implanted eye.The patient was admitted to the hospital and was treated with systemic (iv) and local antibiotics, and systemic and local steroids.On (b)(6) 2014, the surgeon could still not see the retina on eye examination, so he injected antibiotics directly into the eye and rinsed the anterior chamber.He continued the patient on iv antibiotics.On (b)(6) 2014, the surgeon noted continued symptoms of infection in the posterior chamber.He thus decided to perform vitrectomy where he removed debris from the vitreous cavity.He filled the eye with air, left the implant in place, and injected antibiotics and steroids.On (b)(6) 2014, the surgeon reported the eye looked much better, with no hypopyon, and he planned to discharge the patient on (b)(6) 2014.On (b)(6) 2014, the surgeon saw the patient again and reported the inflammation was controlled and the cornea was clear.There were no signs of inflammation and they were further reducing the steroids.However, during that examination, the surgeon noted a recurrence of conjunctival erosion (refer to mdr report 3004081696-2014-00010).

Manufacturer Narrative

There was 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.

• Brand Name: ARGUS II RETINAL PROSTHESIS
• Type of Device: RETINAL PROSTHESIS
• Manufacturer (Section D): SECOND SIGHT MEDICAL PRODUCTS INC.; 12744 san fernando rd bldg 3; sylmar CA 91342 000
• Manufacturer Contact: anne-marie ripley ; 12744 san fernando rd bldg 3; sylmar, CA 91342-0000 ; 8188335034
• MDR Report Key: 4234461
• MDR Text Key: 4977634
• Report Number: 3004081696-2014-00011
• Device Sequence Number: 1
• Product Code: NBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H110002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2014
• Device Model Number: 011014-001-K
• Device Catalogue Number: 011014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR