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

Model Number 011000-002

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

Patient Problems Eye Injury (1845); Fall (1848)

Event Date 09/06/2013

Event Type  Injury  

Event Description

This subject was implanted with the argus ii device on (b)(6) 2008 as part of a clinical trial.This subject had an epiretinal membrane diagnosed in (b)(6) 2009 that was stable for several years and did not require any intervention.However, following a fall the patient experienced in early 2013, an eye exam on (b)(6) 2013 revealed that the epiretinal membrane had separated from the retina, but was still held in place by the tack.The surgeon operated on this subject on (b)(6) 2013 to remove the epiretinal membrane, which he thought may improve the apposition of the array to the retina.As of (b)(6) there was evidence of regrowth of the membrane and the surgeon determined this was a permanent adverse event.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
• Manufacturer Contact: anne-marie ripley ; 12744 san fernando rd bldg 3; sylmar, CA 91342 ; 8188335034
• MDR Report Key: 4223207
• MDR Text Key: 5077835
• Report Number: 3004081696-2014-00005
• Device Sequence Number: 1
• Product Code: NBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2009
• Device Model Number: 011000-002
• Device Catalogue Number: 011000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2013
• Initial Date FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2007
• 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: 56 YR