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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a lynx system device was implanted during a total vaginal hysterectomy, bilateral salpingo-oophorectomies, sacrospinous vault suspension, sub urethral placement of sling with the top-bottom technique using lynx and posterior colporrhaphy procedure performed on (b)(6), 2016, for the treatment of complete procidentia, uterovaginal prolapse, cystocele, rectocele and stress urinary incontinence.The patient was diagnosed with urinary retention after sling which was worsening over time.The patient then underwent vaginal sling removal, cystoscopy and urethrolysis on (b)(6), 2017.During procedure, it was observed that the previous urethral sling was palpated.Using metz scissors, this was separated in its entirely from urethra.It was then incised and a segment was removed.The patient tolerated the procedure well.The patient was extubated and taken to recovery.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2017, was chosen as the best estimate based on the revision date.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6) block h6: imdrf patient code e1309 captures the reportable event of worsening of urinary retention after sling.Imdrf impact code f1905 captures the reportable event of excision of vaginal sling removal.Imdrf impact code f2203 captures the reportable event of cystoscopy procedure.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18050350
• Report Number: 3005099803-2023-05909
• Device Sequence Number: 18162104
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/01/2023

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: 11/03/2018
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: ML00003277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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: 64 YR
• Patient Sex: Female