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

Model Number	M0068503000
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	05/16/2007
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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): 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
• Report Number: 3005099803-2023-04060
• Device Sequence Number: 8884922
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female