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

Model Number 850-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Sleep Dysfunction (2517); Dyspareunia (4505)

Event Date 06/29/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during a procedure performed on (b)(6) 2010.Due to the mesh implant, the patient has experienced repetitive urinary tract infections that increase annually, repeated vaginal infections, repeated vaginal itching, sleep difficulties due to intense pain in both hips, pelvis, lower back, legs and groins.Reported patient consequences include: repeated courses of antibiotics.Switching to a different antibiotic due to the failure of the previous one to have an effect.No improvement in pain from hip cortisone injections.Undergoing x-rays and two pelvic ultrasounds (in 2011 and 2023), with the latter being performed privately due to the long waiting period and the cost was higher.Having to pay for some urine tests in the private sector to obtain urgent results.Painful sexual relations, which led to reduced intimacy or activities.Unable to engage in certain activities, such as cycling, skiing, walking, gardening, etc.Having to cancel planned activities, holidays, and travel.Taking medications such as anti-inflammatory drugs (requiring prescription), acetaminophen, and ibuprofen.Seeking massage therapy to alleviate symptoms.

Manufacturer Narrative

Block h6: imdrf patient code e2330 captures the reportable event of intense pain in both hips, pelvis, lower back, legs, and groins.Imdrf patient code e1310 captures the reportable event of repetitive urinary infections increasing annually.Imdrf patient code e1906 captures the reportable event of repeated vaginal infections.Imdrf impact code f2303 captures the reportable event of repeated antibiotic intake.Imdrf impact code f1202 captures the reportable event of disability.

• Brand Name: OBTRYX SYSTEM - HALO
• 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: 17698789
• MDR Text Key: 322835630
• Report Number: 3005099803-2023-04646
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 850-500
• Device Catalogue Number: M0068505000
• Device Lot Number: 1ML0010501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female