MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

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

Patient Problem Insufficient Information (4580)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6), 2017, the date the sling was implanted, as no event date was reported.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 representative.The implanting surgeon is: dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system was implanted during an anterior colporrhaphy, vaginal sling surgery with solyx vaginal sling boston scientific and cystoscopy procedure performed on (b)(6) 2017.The patient had a known history of stress incontinence as well as a grade 2 cystocele.The risks and complications of her procedures were explained to the patient and she understood and gave informed consent.Even though the physician has explained to the patient that a grade 2 cystocele usually needs no repair, the patient does have vaginal discomfort and associated symptomatic low back pain associated with the cystocele.Thus, the physician and the patient discussed the 3 forms of repair: the vaginal mesh, primary colporrhaphy, and the facia lata graft.Moreover, the patient understood the contraindications as well.As reported by the patient's attorney, the patient had experienced an unspecified injury.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 15535559
• MDR Text Key: 301092004
• Report Number: 3005099803-2022-05584
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• 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: 10/04/2022

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 Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/04/2022
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic