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); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Injury (2348); Dysuria (2684); Insufficient Information (4580)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.(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 device was implanted into the patient during a procedure performed on (b)(6) 2018.According to the patient's attorney, after the implantation, the patient has experienced pain, dysuria, dyspareunia, urinary retention, incontinence, infections, erosion and urethral damage.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2018.After the implantation, the patient has experienced pain, dysuria, dyspareunia, urinary retention, incontinence, infections, erosion and urethral damage.

Manufacturer Narrative

Additional information: section e block b3 date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at (b)(6).Block h6: patient codes e2006, e1309, e1906, e2330, e1301 and e2401 capture the reportable events of erosion, urinary retention, infections, pain and dyspareunia, dysuria, and urethral damage.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.

• 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: 10704966
• MDR Text Key: 212131400
• Report Number: 3005099803-2020-04548
• 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: 04/19/2021

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: 10/30/2020
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021320634
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other