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 Problems Erosion (1750); Incontinence (1928); Pain (1994); Injury (2348); Depression (2361); Dyspareunia (4505); Insufficient Information (4580)

Event Date 06/15/2010

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during an anterior vaginal repair and cystoscopy procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

A report for this patient and device has also been sent under mfr.Report #3005099803-2021-07247.Any new event information will be sent under mfr report #3005099803-2021-00037.Block a1: (b)(6).Block b3 date of event: date of event was approximated to june 15, 2010, 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); (b)(6).Additional attorney for the patient: (b)(6).Block h6: the following patient codes capture the reportable events below: e2006 - erosion/extrusion; e1405 - dyspareunia; e2401 - "damage;" e2330 - pain.Impact code f12 has been used in the light of the patient had filed a legal claim for an unspecified personal injury related to the device.Impact code f2303 captures the reportable event of medications.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during an anterior vaginal repair and cystoscopy procedure performed on june 15, 2010.As reported by the patient's attorney, the patient has experienced an unknown injury.Additional information received on july 20, 2022/correction: note: this manufacturer report pertains to the second of two devices implanted into the patient.It was reported to boston scientific corporation that a solyx was implanted on (b)(6) 2010.A second solyx device was implanted into the patient during a vaginal sacrocolpopexy, cystoscopy, insertion of suprapubic catheter procedure performed on (b)(6) 2010.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; other pain: bearing down pain; painful intercourse; inability to have intercourse; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2009 the patient commenced psychological medication: pristiq sr 50 mg, anti-depressant to deal with unresolvable issues as a result of mesh/tape injuries and trauma.Treatment duration: 6.5 years.On (b)(6) 2010 the patient commenced other medication: hiprex, to inhibit bacterial growth in bladder.Treatment duration: 12 months.

• 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: 11164607
• MDR Text Key: 226639893
• Report Number: 3005099803-2021-00037
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0ML9112303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 79 KG