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

Model Number	M006850200051
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a tension-free vaginal tape placement, cystoscopy, posterior repair and external anal sphincteroplasty procedure performed on (b)(6) 2011, for the treatment of stress urinary incontinence, grade-4 rectocele and disrupted external anal sphincter.During the procedure, urethral hypermobility was seen, as well as external and sphincter disruption.In addition, the patient tolerated the procedure well and was taken to the postoperative area in excellent condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of may 5, 2011, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.

• Brand Name: ADVANTAGE 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): 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: 17044203
• Report Number: 3005099803-2023-02827
• Device Sequence Number: 14743508
• Product Code: OTN
• UDI-Device Identifier: 08714729719564
• UDI-Public: 08714729719564
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 11/30/2013
• Device Model Number: M006850200051
• Device Catalogue Number: 850-200-05
• Device Lot Number: 1ML0111604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female