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

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

Patient Problems Bacterial Infection (1735); Fistula (1862); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Prolapse (2475); Dysuria (2684); Movement Disorder (4412); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)

Event Date 08/12/2007

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2007 was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was originally reported by the patient's legal representation and additional information was subsequently received.Report source voluntary user medwatch number mw5114293.The following imdrf patient code capture the reportable event of: e1906 - boil type infections.E1901 - bacterial infection.E2330 - pain.E1401 - abnormal vaginal discharge.E1405 - dyspareunia.E2314 - fistula.E1301 - dysuria.E1311 - patient sometimes cannot void right.The following imdrf impact code capture the reportable event of: f12 - serious injury f1202 - patient is fully disabled and experiencing continual body loss without proper medical treatment.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a procedure performed on (b)(6) 2007.The patient reported that she had three surgeries for bladder issues in 2007, 2008, 2009, and 2011.The patient reported continual problems with her body and has not had medical follow up after undergoing several surgeries and bladder mesh insertion.The patient complained of several boil-type infections in her hips, around the vagina, and between the pits of her legs.The patients reports that she feels like she has a ball of tin foil inside her and a fistula.According to the patient, she could not feel her ovaries, and the mesh was prolapsed.The patient could not have a sexual relationship due to pain and infections.She had brown discharge report and had also experienced pink and green discharge.She reports high levels of bacterial vaginosis which is affecting her legs, and has difficulty walking due to pain in her legs.Additionally, the patient has umbilical hernia mesh, causing excessive pain in her belly and between the bladder mesh and umbilical mesh.The patient experienced a very painful voiding and inability to void properly.According to the patient, her doctor refuses to care for her because the devices were implanted at another facility.She reports difficulty finding a doctor that will help her and says she has gone for years without proper medical treatment.Per the patient, there is nothing the doctors can do for her, yet she is fully disabled and experiencing continual body loss without proper medical treatment.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: (b)(6) 2014.Asr exemption number: (b)(4).Pro code: otn.

• 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 IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16385459
• MDR Text Key: 309652783
• Report Number: 3005099803-2023-00547
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2023
• 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
• Patient Sex: Female