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

Model Number M0068505110

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

Patient Problems Dyspnea (1816); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Dizziness (2194); Anxiety (2328); Disability (2371); Patient Problem/Medical Problem (2688)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Tga device incident report reference no.(b)(4) submitted to tga (therapeutic goods administration) by a patient.(b)(4).The complainant indicated that the device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient began to experience recurrent urinary tract infections (uti), and as the year progressed, the time between each uti became shorter.After suffering on her 7th time of having uti, the patient was prescribed with an ongoing low-dose course of antibiotics.Since the surgery, the patient also felt an increased urge to urinate, even though her bladder was far from full.Moreover, after undergoing the cystoscopy and ureteroscopy procedures, the patient was diagnosed with a hypersensitive bladder and abnormally slow voiding, which she neither had these conditions prior the surgery.The patient also noticed an overall decline of her health, suffering from crashing fatigue, flu-like symptoms after minimal exertion, breathlessness, dizziness and crippling panic attacks.These symptoms began towards the end of 2018.Despite quitting her job and minimizing her activities as much as possible, while improving her diet and taking steps to improve her health, the patient still noticed a steady decline of health.Also, intercourse with her partner has been painful since the surgery and has not improved over the period of 2 years.Reportedly, there were no steps have been taken to address the issue.

• Brand Name: OBTRYX II 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: 10904693
• MDR Text Key: 218268236
• Report Number: 3005099803-2020-05560
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2020

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: 11/07/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021359457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability