MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2011

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2011, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during an anterior repair + solyx + cystoscopy procedure performed on (b)(6) 2011 to treat grade 2 cystocele.The procedure was completed with no complications.The patient tolerated the procedure and was taken to the recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unknown injury.

• 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: 17083857
• MDR Text Key: 316749136
• Report Number: 3005099803-2023-02972
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2023

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: 01/31/2014
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML1012002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: White