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

Model Number	M0068502050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Anxiety (2328); Sleep Dysfunction (2517); Weight Changes (2607)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage blue system was implanted into the patient on (b)(6) 2023, during a procedure.On (b)(6) 2023, the patient experienced a urinary tract infection and was treated with antibiotics.The infection reoccurred on (b)(6) 2023, and was treated again with antibiotics.The patient experienced burning of the vulva, labia majora, perineum, and vagina, along with pelvic pain.The patient currently finds it impossible to sit down.She is also experiencing pain, insomnia, asthenia, and anxiety.
Additional Manufacturer Narrative
Block h6: imdrf patient code (b)(6) captures the reportable event of anxiety.Imdrf patient code (b)(6) captures the reportable event of asthenia.Imdrf patient code (b)(6) captures the reportable event of burning sensation of the vulva, labia majora, perineum, and vagina.Imdrf patient code (b)(6) captures the reportable event of insomnia.Imdrf patient code (b)(6) captures the reportable event of urinary tract infection.Imdrf impact code (b)(6) captures the usage of antibiotics for treatment.Imdrf impact code (b)(6) captures disability experienced by patient.
Event or Problem Description
It was reported to boston scientific corporation that an advantage blue system was implanted into the patient on (b)(6) 2023, during a procedure.On june 8, 2023, the patient experienced a urinary tract infection and was treated with antibiotics.The infection reoccurred on june 18, 2023, and was treated again with antibiotics.The patient experienced burning of the vulva, labia majora, perineum, and vagina, along with pelvic pain.The patient currently finds it impossible to sit down.She is also experiencing pain, insomnia, asthenia, and anxiety.
Additional Manufacturer Narrative
Model number and catalog number have been corrected.Correction to block h10.Reportable patient codes have been corrected and non-reportable codes have been omitted.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f1202 captures the disability experienced by the patient.Imdrf impact code f2303 captures the usage of antibiotics for treatment.
Event or Problem Description
It was reported to boston scientific corporation that an advantage blue system was implanted into the patient on (b)(6) 2023, during a procedure.On (b)(6) 2023, the patient experienced a urinary tract infection and was treated with antibiotics.The infection reoccurred on (b)(6) 2023, and was treated again with antibiotics.The patient experienced burning of the vulva, labia majora, perineum, and vagina, along with pelvic pain.Two weeks before her consultation on (b)(6) 2023, she was seen due to perineal pain.The ultrasound did not show any rpm.Local treatment has been recommended with alpha-blocker.On (b)(6) 2023, the patient presented with non-lateralized intravaginal pain, described as pinch-like.Today's clinical examination is reassuring; she has good healing and vaginal trophicity.Has moderate lateral vaginal pain, mainly on the right side and does not report pain on one side more than the other.Pelvic mri has been scheduled.She is to start on laroxyl at a progressive dose.This consultation is part of her urological follow-up.The urine cytobacteriological testing (ecbu) performed on (b)(6) 2023, came back sterile.On (b)(6) 2023, mri of the pelvic shows no notable abnormalities.Indication: assessment of perineal pain after tension-free vaginal tape (tvt) insertion with notion of abnormality on palpation at right-sided tv.On (b)(6) 2023, radiology imaging was performed.Emg and trans labial ultrasound are to follow.The patient currently finds it impossible to sit down.She is also experiencing pain, insomnia, asthenia, and anxiety.Her current state and clinical consequences are as follows: fatigue; daily pain; difficulties in practicing one's profession as she is a self-employed nurse; altered quality of life; return to sport impossible; must take laroxyl to reduce pain; and increased appetite and weight gain.
Additional Manufacturer Narrative
Block b5 and h6 have been updated based on the new information received on october 6, 2023.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f1202 captures the disability experienced by the patient.Imdrf impact code f2303 captures the usage of antibiotics for treatment.

• Brand Name: ADVANTAGE BLUE SYSTEM
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17379090
• Report Number: 3005099803-2023-03851
• Device Sequence Number: 6118350
• Product Code: OTN
• UDI-Device Identifier: 08714729961918
• UDI-Public: 08714729961918
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Model Number: M0068502050
• Device Catalogue Number: 850205
• Device Lot Number: 0030946341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 10/06/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/22/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Female