MAUDE Adverse Event Report: MENTOR CPX 2 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3546213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); No Code Available (3191)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.The device history record (dhr) was reviewed on (b)(6) 2018, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: unknown mentor saline implant.(b)(4).
Event or Problem Description
It was reported (via fda medwatch) that a female patient of unknown age who underwent breast prostheses implantation with mentor saline implants on (b)(6) 2004 reported breast implant illness.The patient reported that she has been feeling terrible for the last 10+ years, and has seen multiple doctors, has had multiple imaging, testing, and physical therapy but her symptoms remain unresolved.The patient reports bone pain, neck and back pain, brain fog, severe fatigue, impaired concentration affecting driving, stomach and digestive issues, eye problems, poor libido, and depression.All the tests come back negative for lyme disease.The patient reported that one physician believes she has fibromyalgia and another said she may have beginning stages of osteo-arthritis.The patient reports her quality of life is very poor and that she eats healthy, takes vitamins, but has difficulty exercising due to pain and fatigue.The patient did research and believes it is breast implant illness.The patient cannot afford to get them removed but is tired of feeling sick.No product issue, such as deflation, was reported.See manufacturer report number 1645337-2018-03281 for contralateral prosthesis report.
Additional Manufacturer Narrative
On 18-oct-2021, mentor received additional information about the event.The patient was scheduled to undergo bilateral explantation on (b)(6) 2021.Reason for device explant and/or reoperation: autoimmune disorder.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 2 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• MDR Report Key: 7550661
• Report Number: 1645337-2018-03282
• Device Sequence Number: 1775262
• Product Code: LCJ
• UDI-Device Identifier: 00081317002260
• UDI-Public: 00081317002260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2007
• Device Model Number: 3546213
• Device Catalogue Number: 3546213
• Device Lot Number: 271355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention