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

Catalog Number	3544750
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Date of Event	08/27/2015
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: rupture and paresthesia.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation primary with a mentor memorygel breast implant 750cc and experienced ¿bad pain in both breast, pushing on her nerves and are not the same shape they use to be.Swelling and burning sensation, numbness, tightness in her chest.They have gotten severely worse since her surgery.She is sleeping a lot to get out of the pain.Every time she moves her arms her muscles flex and it is painful in her arms.In addition, there is possible bilateral rupture.As a result, the patient had undergone removal on (b)(6) 2019.This medwatch is for the left breast implant.
Additional Manufacturer Narrative
On 9/18/2019, it was reported to mentor that the patient has a history of breast cancer.Both implants had gel bleed and they were intact.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6)2019, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 10/7/2019, during evaluation of the sample it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No additional anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: 8950003
• Report Number: 1645337-2019-17317
• Device Sequence Number: 11403737
• Product Code: FTR
• UDI-Device Identifier: 00081317003953
• UDI-Public: 00081317003953
• Combination Product (Y/N): N
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2020
• Device Catalogue Number: 3544750
• Device Lot Number: 6900387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 09/18/2019; 10/07/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/11/2019; 09/18/2019; 10/08/2019
• 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: 59 YR