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

Model Number 850-200

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

Patient Problems Erosion (1750); Incontinence (1928); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Dyspareunia (4505); Insufficient Information (4580)

Event Date 01/14/2002

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage sling was implanted into the patient on (b)(6) 2001.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; recurrent incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6) 2002 the patient commenced pain medication: panadeine forte to reduce pain.Treatment duration: 20.On (b)(6) 2004 the patient commenced pain medication: vioxx to reduce inflammation.Treatment duration: 4 years.On (b)(6) 2005 the patient commenced psychological medication: zoloft/now duloxetine for the treatment of: depression/anxiety.Treatment duration: 16 years.On (b)(6) 2007 the patient commenced injections (not associated with surgical treatment): steroid injection to reduce inflammation and pain in lower back.Treatment duration: 4.On (b)(6) 2018 the patient commenced topical treatment (including oestrogen cream): estradiol gel for vaginal atrophy and dryness.Treatment duration: 2 years.

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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.

• 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: 12930545
• MDR Text Key: 286873937
• Report Number: 3005099803-2021-07303
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• 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: 12/04/2021

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 Model Number: 850-200
• Device Catalogue Number: 850-200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 70 KG