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 05/17/2013

Event Type  Injury  

Event Description

This patient was implanted with the argus ii device on (b)(6) 2012.This patient is participating in a (b)(4) study of the argus ii.On (b)(6) 2013, the patient was diagnosed with conjunctival erosion caused by the mersilene suture on the coil suture tab perforating the conjunctiva.At that time, the surgeon decided to monitor the situation rather than to intervene.On (b)(6) 2013, the surgeon decided to operate on the patient to revise the sutures.On (b)(4) 2013, the subject underwent a procedure to replace the suture and re-suture the conjunctiva closed.The event was considered resolved on (b)(6) 2013.There was no defect or malfunction of the device associated with this event.

Manufacturer Narrative

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: 4234462
• MDR Text Key: 16628731
• Report Number: 3004081696-2014-00009
• 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: 05/17/2013

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
• Date Manufacturer Received: 05/17/2013
• 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