MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502110

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Anxiety (2328); Depression (2361); Dysuria (2684); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 11/02/2021

Event Type  Injury  

Event Description

*note: this manufacturer report pertains to one of the two devices implanted during the same procedure.Refer to manufacturer report number 3005099803-2023-03320 for upsylon device.It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2021.As reported by the patient's attorney, the patient had suffered pelvic pain, back pain, mesh erosion, infections, urinary incontinence, dysuria and failed sling.She also claimed to have suffered pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment and permanent physical injury.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2021, 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 codes e2006, e2330, e1906, e1301 and e2401 capture the reportable events of mesh erosion; pelvic pain, back pain, pain and suffering; infections; dysuria; and physical impairment.Imdrf impact code f1204 captures the reportable event of permanent physical injury.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 17185384
• MDR Text Key: 317725594
• Report Number: 3005099803-2023-03318
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0026685708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female