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

Catalog Number 850-300

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

Patient Problems Prolapse (2475); Urinary Incontinence (4572)

Event Date 08/15/2011

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2011 was chosen as a best estimate based on the date of the removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).The revision surgeon is dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a lynx system was implanted during a suburethral mesh sling procedure performed on (b)(6) 2004 for the treatment of stress urinary incontinence and hypermobile urethra.A careful inspection with the bladder distended revealed no evidence of compromise of the bladder.The patient was able to be awakened and taken to recovery room in a good condition.On (b)(6) 2011, the patient underwent a removal of tension-free vaginal tape and anterior and posterior colporrhaphy procedures.Her preoperative diagnosis includes stress urinary incontinence, anterior and posterior pelvic organ prolapse, and failed sling procedure.Her postoperative diagnosis includes stress urinary incontinence with failed sling procedure, anterior and posterior, pelvic organ prolapse stage 2.The mesh was encountered at approximately one centimeter below the urethral meatus.Tags were applied to the edges of the mesh and the mesh was carefully dissected in the directed of the genitourinary membrane initially to the patient's right and a three-centimeter graft was removed.Similar procedure was performed on the left and three and a half centimeters graft was removed from this side.The bleeding was minimal and well-controlled with cautery and surgifoam.Vaginal packing was inserted at the completion of the procedure.Rectal exam was performed and no evidence of suture was noted penetrating rectal mucosa.The patient tolerated the procedure well and was taken to the recovery room awake and in stable condition.

• 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; spencer IN 47460
• Manufacturer Contact: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15758279
• MDR Text Key: 303295599
• Report Number: 3005099803-2022-06557
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 11/09/2022

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
• Device Catalogue Number: 850-300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/09/2022
• 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: 38 YR
• Patient Sex: Female