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 Erosion (1750)

Event Date 11/22/2013

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 argus ii.On (b)(6) 2013, this subject was diagnosed with a recurrence of conjunctival erosion over the coil suture tab.On (b)(6) 2013, the patient underwent revision surgery in which the surgeon cut off the coil suture tab and placed a pericardial patch oer the edge of the coil.He then re-sutured the conjunctiva with sutures.The issue was considered resolved in (b)(6) 2014.There was no defect or malfunction of the device associated with this event.

Manufacturer Narrative

This event represents a recurrence of a previous event reported in mdr#3004081696-2014-0009.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: 4234453
• MDR Text Key: 5002429
• Report Number: 3004081696-2014-00010
• 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: 11/27/2013

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2013
• 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: 47 YR