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

Model Number	M0068503001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Micturition Urgency (1871); Depression (2361); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)
Date of Event	05/18/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an obtryx device implanted during a procedure and has since experienced complications, including abdominal pain, bladder neck obstruction, mixed incontinence and major depression.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 b3 date of event: the exact event onset date is unknown.The provided event date of may 18, 2015, 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).Block h6: the imdrf patient codes capture the reportable events of: patient code e2328 captures the reportable event of bladder neck obstruction.Patient code e1002 captures the reportable event of abdominal pain.Patient code e020202 captures the reportable event of major depression.Patient code e0206 captures the reportable event of physical pain and mental anguish.The imdrf impact code capture the reportable event of: impact code f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device.
Additional Manufacturer Narrative
Blocks a2, b2 (outcomes attrib to adv event), b5, and h11 have been updated based on the additional information received on july 22, 2025.Additionally, blocks d1 has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 18, 2015, 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).Block h6: the imdrf patient codes capture the reportable events of: patient code e2328 captures the reportable event of bladder neck obstruction.Patient code e1002 captures the reportable event of abdominal pain.Patient code e020202 captures the reportable event of major depression.Patient code e0206 captures the reportable event of physical pain and mental anguish.The imdrf impact code capture the reportable event of: impact code f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device impact code f1905 captures the reportable event of revision procedure.
Event or Problem Description
It was reported that the patient had a lynx device implanted during a procedure and has since experienced complications, including abdominal pain, bladder neck obstruction, mixed incontinence and major depression.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.Due to bladder neck obstruction and a history of suburethral sling placement, the patient underwent sling revision on (b)(6) 2022.An inverted u-shaped vaginal incision was made to access the surgical field.The urethral complex was identified and exposed.Intraoperatively, the previously placed sling was found to be partially transected, resulting in kinking of the bladder neck.The sling was excised bilaterally through the retropubic space, effectively releasing the urethra.The vaginal wall was then closed using absorbable sutures.Cystoscopy was performed via the urethra, confirming no evidence of bladder or urethral injury.The patient was discharged home in stable condition with appropriate medications and follow-up instructions.
Additional Manufacturer Narrative
Additional information: block b7.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 18, 2015, 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).Block h6: the imdrf patient codes capture the reportable events of: patient code e2328 captures the reportable event of bladder neck obstruction.Patient code e1002 captures the reportable event of abdominal pain.Patient code e020202 captures the reportable event of major depression.Patient code e0206 captures the reportable event of physical pain and mental anguish.The imdrf impact codes capture the reportable event of: impact code f12 captures the reportable event of the patient had filed a legal claim for the personal injuries related to the device.Impact code f1905 captures the reportable event of revision procedure.
Event or Problem Description
It was reported that the patient had an obtryx device implanted during a procedure and has since experienced complications, including abdominal pain, bladder neck obstruction, mixed incontinence and major depression.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.Due to bladder neck obstruction and a history of suburethral sling placement, the patient underwent sling revision on (b)(6) 2022.An inverted u-shaped vaginal incision was made to access the surgical field.The urethral complex was identified and exposed.Intraoperatively, the previously placed sling was found to be partially transected, resulting in kinking of the bladder neck.The sling was excised bilaterally through the retropubic space, effectively releasing the urethra.The vaginal wall was then closed using absorbable sutures.Cystoscopy was performed via the urethra, confirming no evidence of bladder or urethral injury.The patient was discharged home in stable condition with appropriate medications and follow-up instructions.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22114802
• Report Number: 2124215-2025-28912
• Device Sequence Number: 20622205
• Product Code: OTN
• UDI-Device Identifier: 08714729718956
• UDI-Public: (01)08714729718956(17)180131(10)ML00002818
• 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: 2015
• 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): 10/24/2025

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: 01/31/2018
• Device Model Number: M0068503001
• Device Catalogue Number: 8503001
• Device Lot Number: ML00002818
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 09/25/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/08/2025; 10/24/2025
• Date Device Manufactured: 01/21/2015
• 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: 51 YR
• Patient Sex: Female