MAUDE Adverse Event Report: MENTOR MENTOR IMPLANTS

Device Problem Defective Component (2292)

Patient Problems Rheumatoid Arthritis (1724); Fungus (1872); Lupus (1956); Sjogren's Syndrome (2073); Disability (2371)

Event Date 07/13/2015

Event Type  Injury  

Event Description

I had implants put in 10 years ago. I immediately became ill with migraines, rheumatoid arthritis, pots, sjogrens, lupus and celiac disease. I was disabled for many years. I explanted on (b)(6) 2015 and found the valves to my mentor implants were faulty and created a situation where mold was present. I am doing 95% better and don't have any signs of 4 out of 5 autoimmune issues. They ruined 10 years of my life and because of my age, i missed having children because i was so sick.

• Brand Name: MENTOR IMPLANTS
• Type of Device: MENTOR IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 5332814
• Report Number: MW5058779
• Device Sequence Number: 1
• Product Code: FTR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 32 YR
• Patient Weight: 62
• Patient Outcome(s): Life Threatening; Other; Disability