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 Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of february 21, 2023, was chosen as the best estimate based on the implant date.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2330 captures the reportable event of significant pain.Imdrf patient code e0206 captures the reportable event of embarrassment, disfigurement and harm.Imdrf patient code e2401 captures the reportable event of severe and debilitating injuries, serious bodily injury and suffering.Imdrf impact code f12 captures the reportable event of impairment.Imdrf impact code f1202 captures the reportable event of disability.

Event Description

It was reported to boston scientific corporation that an advantage fit blue mid-urethral sling system device was implanted during a transvaginal surgery procedure performed on (b)(6) 2023.The patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm from the implanted mesh.Additionally, the patient had experienced significant mental and physical pain and suffering and had sustained a permanent injury.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, and has incurred economic loss.The patient had sustained suffering, disability, impairment, loss of enjoyment of life, loss of care, comfort, and economic damages.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of february 21, 2023, was chosen as the best estimate based on the implant date.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2330 captures the reportable event of significant pain.Imdrf patient code e0206 captures the reportable event of embarrassment, disfigurement and harm.Imdrf patient code e2401 captures the reportable event of severe and debilitating injuries, serious bodily injury and suffering.Imdrf patient code e2308 captures the reportable event of disfigurement.Imdrf impact code f12 captures the reportable event of impairment.Imdrf impact code f1202 captures the reportable event of disability.

Event Description

It was reported to boston scientific corporation that an advantage fit blue mid-urethral sling system device was implanted during a transvaginal surgery procedure performed on (b)(6) 2023.The patient alleged suffering significant pain, embarrassment, disfigurement, and harm from the implanted mesh.Additionally, the patient had experienced significant mental and physical pain and suffering and had sustained a permanent injury.The patient has sustained and will continue to sustain severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering.The patient had disability, impairment, loss of enjoyment of life, loss of care, comfort, and economic damages.The patient may need additional surgery, treatment, and therapy in the future.

• 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: 17862811
• MDR Text Key: 324826204
• Report Number: 3005099803-2023-05304
• 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,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• 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; Disability
• Patient Sex: Female