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

Model Number M0068507001

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

Patient Problem Insufficient Information (4580)

Event Date 05/28/2013

Event Type  Injury  

Manufacturer Narrative

B3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2013 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.

Event Description

Note: this manufacturer report pertains to the first of three devices used during the same procedure.Please refer to mfr report 3005099803-2023-01850 and 3005099803-2023-01854 for the associated devices.It was reported to boston scientific corporation that a solyx sis system and xenform graft devices were implanted into the patient during a mid-urethral sling operation for stress incontinence, anterior and posterior colporrhaphy with repair of enterocele, insertion of a graft, vaginal colpopexy, hysteroscopy with polypectomy, and dilatation and curettage procedures performed on (b)(6) 2013, for the treatment of pelvic organ prolapse, cystocele, rectocele, enterocele, and endometrial polyps, and genuine stress urinary incontinence.The patient had third-degree prolapse of her uterus, bladder, and rectum, as well as a third-degree posterior defect that was a combined rectocele and enterocele, which were discovered during the procedure.She had a 2 cm polyp that was arising from the anterior uterine wall and appeared to be benign.Her uterus had prolapsed past the hymenal ring.Furthermore, no patient complications were reported during the procedure.The procedure was well tolerated by the patient, who was transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury as a result of the surgery.

• 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): 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: 16755872
• MDR Text Key: 313450107
• Report Number: 3005099803-2023-01849
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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: 04/17/2023

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: 11/30/2015
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: ML00001155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: White