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

Model Number M0068503000

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Scar Tissue (2060); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 05/16/2007

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2007, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6).Phone: (b)(6).Revision surgery surgeon: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: imdrf patient codes e2330, e2328, e1715 and e2337 capture the reportable events of vaginal pain, pelvic pain, left groin pain, pain with coitus and suprapubic pain; urinary stricture; scar tissue; and urethral lysis.Imdrf impact codes f1901 and f1905 capture the reportable events of urethral lysis surgery and mesh excision.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a total vaginal hysterectomy + tvt + anterior and posterior repair procedure performed on (b)(6) 2007, for the treatment of uterine prolapse, cystocele, rectocele and stress urinary incontinence.The procedure was completed with no complications.The patient was taken to the recovery room in good condition.On (b)(6) 2022, the patient had lynx sling removal, urethral lysis, anterior colporrhaphy, and removal of abdominal mesh due to vaginal pain, pelvic pain, left groin pain, pain with coitus, suprapubic pain, and urinary stricture.This was a very difficult surgery due to the severe scarring from previous surgery as well as the right and left sling arms being deep in the obturator muscles.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The entire sling arm was handed off the operative field.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17434240
• MDR Text Key: 320125521
• Report Number: 3005099803-2023-04060
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• 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: 08/01/2023

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
• Device Expiration Date: 03/31/2010
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0ML7032109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female