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 Codes	Erosion (1750); Micturition Urgency (1871)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a boston scientific lynx mid-urethral sling + cystoscopy procedure performed on (b)(6) 2017, for the treatment of mixed incontinence.During this operation, the anterior vaginal wall was somewhat atrophic and felt somewhat scarred and adherent suggestive of mild idiopathic fibrosis.Lidocaine with epinephrine was injected around the urethra.There were no complications, and the patient was in stable condition at the end.On (b)(6) 2022, the patient underwent transvaginal mesh excision and intradetrusor onabotulinumtoxina injection procedure due to vaginal mesh exposure and overactive bladder.Examination showed a 1-1.5cm transverse area of a vaginal mesh exposure at the level of the mid urethra.This extended from just right of the midline to slightly left of the midline and represented the distal edge of the mesh sling.The mesh arms were transected and sent to pathology.Inspection of the wound bed did not identify any injury to the bladder or urethra.Bladder botox injection was then performed.A total of 100 units of botox diluted in 10ml of injection grade saline were injected and a total of 15 injections were utilized.The bladder was drained and reinspected with excellent hemostasis.The patient was awakened and taken to the recovery room in stable condition.
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2017, the 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).Assistant: dr.(b)(6).(b)(6).Block h6: imdrf patient codes e2006 and e1304 capture the reportable events of vaginal mesh exposure at the level of the mid urethra and overactive bladder.Imdrf impact codes f1905 and f1901 capture the reportable events of mesh excision and bladder botox injection.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17772097
• Report Number: 3005099803-2023-04979
• Device Sequence Number: 7163063
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/19/2023

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: 02/14/2018
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0020289678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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: 55 YR
• Patient Sex: Female