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

Model Number M0068502110

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Urinary Tract Infection (2120); Blurred Vision (2137); Numbness (2415); Confusion/ Disorientation (2553); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4) the removed mesh 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.The voluntary user medwatch number is mw5099750.

Event Description

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) 2016.After the implantation, the patient immediately experienced all sorts of immune system issues including allergic reaction (swollen eyes), and urinary tract infection.Couple of years later, the patient became extremely fatigued, groin pain that led to difficulty in standing/rising from sitting position.The patient also developed brain fog, numbness in hands and feet and blurred vision.Reportedly, the patient sought help from primary care that would run test such as routine blood and urinalysis, rheumatologists for joint pain, neurologists for hands and feet going numb and tingling, xrays, mri's, physical therapy for neck and stomach charley horsing, chiropractor, massage therapist, acupuncturist, functional medicine, nephrologist for kidney pain, and endocrinologist to check on thyroid/fatigue.On (b)(6) 2019, the patient had the mesh removed and most of the symptoms had resolved and did not come back.However, she still experiences a few remaining symptoms.

• 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: 11717210
• MDR Text Key: 247248561
• Report Number: 3005099803-2021-01848
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention