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); Discomfort (2330); Disability (2371); No Code Available (3191); Urinary Incontinence (4572)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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

Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a solyx sis system device was implanted during a solyx procedure between around (b)(6) 2017 to around (b)(6) 2018 to treat stress urinary incontinence.As reported by the patient's attorney, after the implantation, the patient has suffered from injuries and disabilities.The personal injury alleged to have been suffered by the patient includes urinary incontinence, urethral erosion/damage, requirement for subsequent procedures including cystoscopies, pudendal blocks, botox injections, excision of the mesh from urethra, chronic and relenting pain together with symptoms arising therefrom.Reportedly, the patient underwent the surgical intervention on (b)(6) 2017 and had further procedures for treatment and mesh removal on (b)(6) 2018.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Additional information: blocks b5 and d6a have been updated based on the additional information received.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this was reported by the patient's legal representation.The device surgeon is: (b)(6).Block h6: patient codes e2006, e2330 and impact codes f1202, f19 capture the reportable events of extrusion, pain, disability and surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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

Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a xenform and a solyx sis system devices were implanted during a xenform and solyx procedure performed on (b)(6) 2017 to treat vaginal prolapse.After the implantation, the patient has suffered from injuries and disabilities.The personal injury alleged to have been suffered by the patient includes urinary incontinence, urethral erosion/damage, requirement for subsequent procedures including cystoscopies, pudendal blocks, botox injections, excision of the mesh from urethra, chronic and relenting pain together with symptoms arising therefrom.Reportedly, the patient had further procedures for treatment and mesh removal on (b)(6) 2018.

• 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
• MDR Report Key: 10564782
• MDR Text Key: 207949771
• Report Number: 3005099803-2020-03904
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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
• Date Manufacturer Received: 03/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR