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	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, 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 implanting surgeon is: dr.(b)(6).(b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic, perineal, and low back pain.E1906 - captures the reportable event of infections.E1405 - captures the reportable event of dyspareunia.E1715 - captures the reportable event of scarring.E1311 - captures the reportable event of further or worsening urinary problems.E0206 - captures the reportable event of loss of enjoyment.The imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for an unspecified personal injury related to the device.
Event or Problem Description
It was reported that the patient had a lynx system implanted during a procedure and has since experienced complications, including pelvic, perineal, and low back pain, infections, dyspareunia, further or worsening urinary problems, scarring, and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.
Additional Manufacturer Narrative
Block h11: blocks a2, b2, b5, b7, d6b, h2, h6, have been updated based on the additional information received on june 30, 2025.Block a2: the provided patient age of 43 years is as of the time of device implantation.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, 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 implanting surgeon is: dr.(b)(6).(b)(6) medical center, united states.The explanting surgeon is: dr.(b)(6) (b)(6) medical center, united states.Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic, perineal, and low back pain.E1906 - captures the reportable event of infections.E1405 - captures the reportable event of dyspareunia.E1715 - captures the reportable event of scarring.E1311 - captures the reportable event of further or worsening urinary problems.E0206 - captures the reportable event of loss of enjoyment.The imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for an unspecified personal injury related to the device.F1903 - mesh excision.
Event or Problem Description
It was reported that the patient had a lynx system implanted during a procedure and has since experienced complications, including pelvic, perineal, and low back pain, infections, dyspareunia, further or worsening urinary problems, scarring, and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.Additional information received: on june 25, 2024, the patient underwent mesh excision surgery.A u-shaped vaginal incision was created to facilitate dissection of the full-thickness vaginal wall from the ureteropelvic ligament.The sling located at the mid-urethral level was identified, divided into right and left halves using a right-angle clamp and curved mayo scissors, and systematically removed.The left portion of the sling was dissected from beneath the urethra, then deep into the retropubic space, separating it from the bladder, urethra, and its attachments to the pubic bone periosteum.Traction on the left sling arm revealed movement in the suprapubic skin, correlating with the original sling placement site.The right half of the sling was similarly dissected from the urethra, bladder, and pubic bone periosteum, allowing confirmation of its suprapubic trajectory.Skin incisions overlying the sling tract were extended and joined to form a single suprapubic access point.Mesh was identified bilaterally and fully dissected from the subcutaneous tissue and rectus fascia.Both the left and right portions of the sling were removed intact.The vaginal incision was irrigated with antibiotics and closed.Cystoscopy confirmed the absence of bladder or urethral injury.The patient was admitted for overnight observation and pain management.She will be discharged without a catheter and prescribed analgesics and a stool softener.Follow-up will be arranged as needed.
Event or Problem Description
It was reported that the patient had a lynx system implanted during a procedure and has since experienced complications, including pelvic, perineal, and low back pain, infections, dyspareunia, further or worsening urinary problems, scarring, and loss of enjoyment of life.Additionally, the patient claims that she has suffered, or may in the future suffer, damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.On (b)(6) 2024, the patient underwent mesh excision surgery.A u-shaped vaginal incision was created to facilitate dissection of the full-thickness vaginal wall from the ureteropelvic ligament.The sling located at the mid-urethral level was identified, divided into right and left halves using a right-angle clamp and curved mayo scissors, and systematically removed.The left portion of the sling was dissected from beneath the urethra, then deep into the retropubic space, separating it from the bladder, urethra, and its attachments to the pubic bone periosteum.Traction on the left sling arm revealed movement in the suprapubic skin, correlating with the original sling placement site.The right half of the sling was similarly dissected from the urethra, bladder, and pubic bone periosteum, allowing confirmation of its suprapubic trajectory.Skin incisions overlying the sling tract were extended and joined to form a single suprapubic access point.Mesh was identified bilaterally and fully dissected from the subcutaneous tissue and rectus fascia.Both the left and right portions of the sling were removed intact.The vaginal incision was irrigated with antibiotics and closed.Cystoscopy confirmed the absence of bladder or urethral injury.The patient was admitted for overnight observation and pain management.She will be discharged without a catheter and prescribed analgesics and a stool softener.Follow-up will be arranged as needed.Pathology of the mesh revealed synthetic mesh, consistent with bladder sling, fibroadipose tissue with hemorrhage and vascular congestion, and no significant inflammation.
Additional Manufacturer Narrative
Block h11: blocks b5 and h6, have been updated based on the additional information received on october 15, 2025.Block a2: the provided patient age of 43 years is as of the time of device implantation.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, 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 implanting surgeon is: (b)(6).The explanting surgeon is: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2330 - captures the reportable event of pelvic, perineal, and low back pain.E1906 - captures the reportable event of infections.E1405 - captures the reportable event of dyspareunia.E1715 - captures the reportable event of scarring.E1311 - captures the reportable event of further or worsening urinary problems.E0206 - captures the reportable event of loss of enjoyment.The imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for an unspecified personal injury related to the device.F1903 - mesh excision.

• 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: 21886610
• Report Number: 2124215-2025-25154
• Device Sequence Number: 3531013
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: (01)08714729718949(17)230302(10)25289644
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 11/14/2025

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 Expiration Date: 03/02/2023
• Device Model Number: M0068503000
• Device Catalogue Number: M0068503000
• Device Lot Number: 0025289644
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 10/15/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/30/2025; 11/14/2025
• Date Device Manufactured: 03/02/2020
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Female