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

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Dyspareunia (4505)

Event Date 03/20/2008

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a lynx suburethral sling placement procedure performed on (b)(6) 2008, for the treatment of stress incontinence secondary to bladder neck hypermobility with a component of detrusor instability.No complications were noted throughout the procedure, and the patient was taken to the recovery room in good condition.Following the procedure, the patient presented with symptoms such as incomplete voiding of the bladder, pain during sexual intercourse, vaginal pain, and scarring in the urethral area.Consequently, on (b)(6) 2022, the patient underwent a sling release and urethral lysis to address these concerns.During the procedure, it was noted that the sling was located at the bladder neck and under tension.Accordingly, the sling was released from the underlying sub-urethral tissues and incised in the midline, resulting in approximately 1 cm of release.To further alleviate any adhesions, urethral lysis was performed using sharp dissection.The sling was then dissected laterally into the retropubic space on both the left and right sides.The mesh was removed as far lateral as possible and excised bilaterally.The patient exhibited excellent hemostasis and tolerated the procedure well.She was then subsequently transferred to the recovery room in excellent condition.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2008, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device 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 physician is: dr.(b)(6).(b)(6) health center.(b)(6).The physician who performed the revision is: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1405 - has been used to capture the reported event of painful intercourse.E2006 - has been used to capture the reported event of sling was located at the bladder neck.E1715 - has been used to capture the reported event of scarring in the urethral area.E1309 - has been used to capture the reported event of incomplete bladder emptying.E2330 - has been used to capture the reported event of vaginal pain.The following imdrf impact codes capture the reportable events of: f1905 - has been used to capture the reported event of sling 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: 17477489
• MDR Text Key: 320569150
• Report Number: 3005099803-2023-04059
• 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: 08/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• 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: 39 YR
• Patient Sex: Female