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 Injury (2348); Insufficient Information (4580)

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2014, 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 device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, after the implantation, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, after the implantation, the patient experienced an unknown injury.The procedures performed on (b)(6) 2014 were suburethral sling and cystoscopy eua.Findings include hoofing over the urethral orifice with minimal support of the urethra and dropping.Marked scarring under the urethra and anterior wall with normal cervix were noted.There were no pelvic masses but difficult exam with pr being normal.It was also noted that the para urethral sulcus was very scarred with difficulty dissection especially with the left side to the obturator internus and moderate det hyper with back flow at 400 ml but there was no urinary incontinence.There were no patient complications reported at the conclusion of the procedure.On (b)(6) 2019, the patient underwent a revision procedure.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2014, 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 code 2348 captures the reportable event of unknown injury.Conclusion code 4316 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.Block h11: blocks g2 and h7 have been corrected.Blocks b5, e1, h6 and h10 have been updated based on the additional information received on february 10, 2023.Block e1: this complaint was received as litigation from a legal source in australia.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision procedure surgeon is: (b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f1905 captures the reportable event of revision surgery performed.Impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.

• 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: 11175542
• MDR Text Key: 227062118
• Report Number: 3005099803-2021-00090
• 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: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00001760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female