MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX? SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068503000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of november 4, 2024, was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2006 for mesh extrusion, e0506 for vaginal bleeding, e1405 for dyspareunia, e2330 for pain, contributing to decreased ambulation, e2308 for disfigurement.The following imdrf impact codes capture the reportable events below: f23 for the need for suture trimming, f1903 for mesh removal surgery.
Event or Problem Description
It was reported that following implantation of the lynx device, the patient experienced multiple injuries, including mesh exposure, vaginal bleeding, dyspareunia, decreased ambulation, the need for catheterization and suture trimming, ultimately requiring mesh removal surgery on (b)(6) 2024.As a result of the mesh, she has suffered significant physical and emotional pain and suffering, financial burdens, and disfigurement, and may require additional surgery and long-term medical care, with continuing physical, mental, and economic harm.
Additional Manufacturer Narrative
Block h2: additional information.Blocks a2 (date of birth) and b5 (describe event or problem) have been updated based on the additional information received.Correction: block b3 (date of event) have been updated from (b)(6) 2024 (explant date ) to april 18, 2024.Block b3: the exact event onset date is unknown.The provided event date of april 18, 2024, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2006 for mesh extrusion.E0506 for vaginal bleeding.E1405 for dyspareunia.E2330 for pain, contributing to decreased ambulation.E2308 for disfigurement.The following imdrf impact codes capture the reportable events below: f23 for the need for suture trimming.F1903 for mesh removal surgery.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient was implanted with a lynx system device during a mid-urethral sling placement and anterior vaginal wall repair to treat stress urinary incontinence (sui) and cystocele.Following a robotic hysterectomy, an examination under anesthesia revealed persistent anterior vaginal laxity due to the cystocele.An anterior vaginal incision was made, and the pubocervical fascia was dissected and plicated using interrupted sutures to restore support.A mid-urethral sling was then placed via two suprapubic stab incisions, passed through the retropubic space, and adjusted to achieve appropriate tension beneath the urethra.Cystoscopy confirmed no injury to the bladder or urethra.Excess vaginal mucosa was excised, and the incision was closed.The patient received a foley catheter and vaginal packing.The procedure was completed without complications, and the patient was transferred to recovery in stable condition.Following the implantation of the device, the patient experienced multiple injuries, including mesh exposure, vaginal bleeding, dyspareunia, decreased ambulation, the need for catheterization and suture trimming, ultimately requiring mesh removal surgery on (b)(6) 2024.As a result of the mesh, she has suffered significant physical and emotional pain and suffering, financial burdens, and disfigurement, and may require additional surgery and long-term medical care, with continuing physical, mental, and economic harm.

• Brand Name: LYNX? SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22367202
• Report Number: 2124215-2025-41241
• Device Sequence Number: 8091791
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: (01)08714729718949(17)270129(10)33318685
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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 Model Number: M0068503000
• Device Catalogue Number: M0068503000
• Device Lot Number: 0033318685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 11/07/2025
• Date Device Manufactured: 01/30/2024
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female