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 Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).This event was reported by the patient's legal representative.The implanting surgeon is: (b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to one of two devices implanted into this patient during the same procedure.It was reported to boston scientific corporation that an advantage fit system and an upsylon y-mesh were implanted into the patient during a laparoscopic sacro-colpopexy, mid urethral sling advantage fit and cystoscopy procedure on (b)(6), 2017.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; other pain: stomach, buttock; painful intercourse; difficulties with bowel motions; incontinence not present before implant; damage; psychiatric injury.Nonsurgical treatments: on (b)(6), 2021 the patient commenced pain medication: cbd oil for pain management.Treatment duration: daily - approx 2021.On (b)(6), 2017 the patient commenced psychological medication: amitriptyline (50mg at night), pain medication: pevaatiapain (50mg at night), and pain medication: duloxitine (90mg in morning) for pain management.Treatment duration: daily - approx 2017.On (b)(6), 2017 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) to assist with pain and pelvic floor.Treatment duration: few sessions.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15602010
• MDR Text Key: 301722224
• Report Number: 3005099803-2022-06048
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0000053299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 127 KG