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

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(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 filed a legal claim for an unspecified personal injury related to the device.
Event or Problem Description
It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a robotic-assisted laparoscopic hysterectomy, bilateral salpingectomy, cystoscopy, and mid-urethral sling placement procedure performed on (b)(6) 2016, for the treatment of abnormal uterine bleeding, anemia, and pelvic pain.During the exam under anesthesia, it was observed that the uterus was slightly enlarged and in a globular shape.It was found to be mobile and anteverted.No masses were detected in the surrounding areas.The laparoscopic findings showed a similar enlarged globular uterus, but both fallopian tubes and ovaries appeared normal.The liver edge was also normal, but the gallbladder was slightly enlarged.After the cystoscopy, it was confirmed that bilateral ureteral jets were present, and there was no damage or suture on the bladder.In addition, the patient underwent the procedure without any issues and was successfully awakened from anesthesia.Afterward, she was moved to the recovery area and remained in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• Brand Name: SOLYX SIS SYSTEM
• Common Device Name: 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: 17426921
• Report Number: 3005099803-2023-04056
• Device Sequence Number: 12676842
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• 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): 07/31/2023

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: 06/22/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019399953
• 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: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Female