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); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 04/12/2011

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2011 (implant date) 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.Patient's additional lawyers: (b)(6).The device was implanted at (b)(6), by dr.(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 during a procedure performed on (b)(6) 2011 to treat stress urinary incontinence, uterine prolapse, cystocele, and rectocele.As per reported by the patient's attorney, the patient has a negative response to the implanted device that promotes inflammation of the pelvic tissue and contributes to the formation of severe adverse reactions to the mesh.After the procedure, the patient experienced pain, development of bladder stones, and mesh erosion; consequently requiring several mesh removal and reparative surgeries.The patient has to undergo operations to locate and remove mesh, and operations to attempt to repair pelvic organs, tissue, and nerve damage.Additionally, she has to use pain control and other medications, and injections into various areas of the pelvis, spine, and the vagina.The patient also has to undergo operations to remove portions of the female genitalia.These surgical treatments and attendant medical care were performed at a different healthcare facility on (b)(4) 2018.Reportedly, as a result of the device implantation, the patient has experienced significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures.

• 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: 9586903
• MDR Text Key: 175058684
• Report Number: 3005099803-2019-06420
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2020

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: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• 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): Required Intervention