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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Dyspareunia (4505)

Event Date 11/10/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx device was used during a trans obturator sub urethral and sling tape cystoscopy procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence.On (b)(6) 2021, the patient was diagnosed with vaginal pain, muscular groin pain and leg pain.Additionally, she was diagnosed with dyspareunia, or pain during intercourse.The patient underwent a removal of the obtryx sling, removal of mesh with an exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection, and mesh removal from the deep obturator internus muscles.And lastly underwent an anterior colporrhaphy.It was noted that the surgery was difficulted by scarring that required the mesh to be removed from the pelvic bones.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6)2021, was chosen as a best estimate based on the date of the explantation.Blocks d4, h4: the complainant was unable to provide the suspect 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 implant surgeon is: (b)(6).Block h6: imdrf patient code e2330 captures the reportable event of vaginal pain, leg pain and muscular groin pain.Imdrf patient code e1405 captures the reportable event of pain with intercourse.Imdrf patient code e1715captures the reportable event of scarring.Imdrf impact codes f1903 captures the reportable events of entire obtryx mesh removal.

• Brand Name: LYNX SYSTEM
• Type of Device: 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17713006
• MDR Text Key: 322990709
• Report Number: 3005099803-2023-04775
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female