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

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency / Polyuria (2275); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572)
Date of Event	02/07/2023
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 february 7, 2023, was chosen as a best estimate based on the date of mesh implant.Blocks d4, h4: the complainant was unable to provide the suspected device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting and first revising physician is: dr.(b)(6).The second revising physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion, e1405 - dyspareunia, e2330 - pain, e1906 - recurrent infection.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient was implanted with a lynx system device.As a result of the mesh implant, the patient experienced dyspareunia, chronic abdominal and pelvic pain, erosion, recurrent infection, recurrence of urinary incontinence, and vaginal scarring.On (b)(6) 2023, the patient had revision surgery of the implanted device.On (b)(6) 2023, the patient underwent a second revision/excision of the implanted device to relieve her erosion and pain.She claimed to have suffered severe pain, unnecessary expense, embarrassment, disfigurement, and harm as a result of the implantation.Additionally, the patient may have to undergo additional surgery in the future and may continue to suffer significant pain, and unnecessary medical expenses for medical care, treatment, and therapies long into the future.Furthermore, she sustained and will continue to sustain in the future, the following damages as a result of the implantation: severe and debilitating injuries, serious bodily injury, mental and physical pain, and suffering, and has incurred economic loss.
Event or Problem Description
It was reported that the patient was implanted with an obtryx ii system - curved device.As a result of the mesh implant, the patient experienced dyspareunia, chronic abdominal and pelvic pain, erosion, recurrent infection, recurrence of urinary incontinence, and vaginal scarring.On (b)(6), 2023, the patient had revision surgery of the implanted device.On (b)(6), 2023, the patient underwent a second revision/excision of the implanted device to relieve her erosion and pain.She claimed to have suffered severe pain, unnecessary expense, embarrassment, disfigurement, and harm as a result of the implantation.Additionally, the patient may have to undergo additional surgery in the future and may continue to suffer significant pain, and unnecessary medical expenses for medical care, treatment, and therapies long into the future.Furthermore, she sustained and will continue to sustain in the future, the following damages as a result of the implantation: severe and debilitating injuries, serious bodily injury, mental and physical pain, and suffering, and has incurred economic loss.
Additional Manufacturer Narrative
H2 additional information: products details in blocks b5, d4, and h4 have been updated.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6), 2023, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.The implanting and first revising physician is: dr.(b)(6).(b)(6) facility.Phone: (b)(6).The second revising physician is: dr.(b)(6).(b)(6) facility.Phone: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion.E1405 - dyspareunia.E2330 - pain.E1906 - recurrent infection.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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: 21732547
• Report Number: 2124215-2025-17748
• Device Sequence Number: 11789339
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: (01)08714729839255(17)251009(10)30310111
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/26/2026

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: 10/09/2025
• Device Model Number: M0068504110
• Device Catalogue Number: M0068504110
• Device Lot Number: 0030310111
• 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: 05/28/2025; 05/28/2026
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/20/2025; 06/26/2026
• Date Device Manufactured: 10/10/2022
• 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: 45 YR
• Patient Sex: Female