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

Device Problem Positioning Problem (3009)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Pain (1994); Suicidal Ideation (4429); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 03/18/2018

Event Type  Injury  

Manufacturer Narrative

Block b3, d6a: the reported event date was march 18, 2018, but the reported implant date was (b)(6) 2018.Further clarification regarding the discrepancy of these dates is not available as the event was reported anonymously.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e0123 captures the reportable event of nerve damage.Imdrf patient code e2006 captures the reportable event of extrusion.Imdrf impact code f1903 captures the reportable event of device explantation.Imdrf impact code f1202 captures the reportable event of disability.

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on an unknown date.After device implantation, the patient woke up with tightness sensation.She had experienced bleeding everyday, pain, nerve pain, nerve damage, painful walking, pain during sexual intercourse, mesh extrusion, fecal and urinary incontinence.Due to constant nerve pain associated with the device, the patient could not work anymore, destroyed her marriage and financial situation and had a suicide ideation.On (b)(6) 2019, the patient underwent a mesh removal procedure.The physician stated that the entire mesh was removed.The patient now takes a "constant cocktail of medications" to try to deal with her symptoms.

• Brand Name: ADVANTAGE 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 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18374808
• MDR Text Key: 331122819
• Report Number: 2124215-2023-70261
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention