MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: generalized illness.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation procedure with mentor memoryshape breast implant 300cc gel breast prostheses and suffered several unexplained systemic symptoms, including fatigue, brain fog, and shooting random pain in her chest.The patient reported that her implants are making her sick and she feels like she has breast implant illness.No device issue such as rupture was reported.The root cause of the patient¿s symptoms is unclear.As a result, the patient underwent bilateral explantation on (b)(6) 2020.This medwatch report is for the right breast prosthesis.
Additional Manufacturer Narrative
On 06-may-2020, mentor received additional information about the event.It was initially reported that the patient underwent bilateral explantation on (b)(6) 2020.New information states that the patient underwent bilateral explantation on (b)(6) 2020.The patient did not receive replacement devices after explantation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 09-jun-2020, the mentor failure analysis lab received the device for evaluation.On 11-jun-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient experienced symptoms of generalized illness.During the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.As part of our quality process, the manufacturing records of this 7445447 lot number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Generalized illness complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9934225
• Report Number: 1645337-2020-05391
• Device Sequence Number: 14132556
• Product Code: FTR
• UDI-Device Identifier: 00081317005186
• UDI-Public: 00081317005186
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

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: 03/23/2022
• Device Model Number: 3341102
• Device Catalogue Number: 3341102
• Device Lot Number: 7445447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 06/09/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/08/2020; 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR