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 Pain (1994); Urinary Frequency (2275); Depression (2361); Weight Changes (2607); Dysuria (2684); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Fecal Incontinence (4571); Insufficient Information (4580)

Event Date 10/09/2016

Event Type  Injury  

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: other: tga device incident report reference no.87233; submitted to tga (therapeutic goods administration) by the patient.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f1202 captures the reportable event of unable to move.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a procedure performed on an unknown date.The patient reported pain with sex, coughing, sneezing, jumping, and emptying bowels and bladder as a result of the implant.She claimed to have bowel incontinence and wakes up multiple times per night to empty her bladder and sometimes her bowel too.Furthermore, the patient reportedly experienced loss of love life at the age of 29 as a result of device-related pain.She experienced mental anguish and depression; weight gain due to pain and inability to move; and associated issues due to weight gain.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17103136
• MDR Text Key: 316937276
• Report Number: 3005099803-2023-02927
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2023
• 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): Disability