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 Chest Pain (1776); Fatigue (1849); Headache (1880); Incontinence (1928); Muscular Rigidity (1968); Pain (1994); Pneumonia (2011); Blurred Vision (2137); Injury (2348); Disability (2371); Cognitive Changes (2551); No Code Available (3191)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other: tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by a healthcare professional/user.The complaint device 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 into the patient during a procedure performed on (b)(6) 2016.According to the complainant, following the implantation, the patient experienced chest pains, hospitalization, multiple pneumonia and pleurisy (no bacteria detected), chronic productive cough leading to upper respiratory dysfunction, chronic back and buttocks pain and bladder leakage while walking.The patient also experienced autoimmune symptoms including chronic fatigue, joint pain and stiffness, vision disturbance, memory loss, headaches, and passing out.The patient initially needed to reduce working hours to 3 hours a day but eventually has to permanently leave job.Subsequently, the patient underwent mesh removal on (b)(6) 2018.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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): 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: 10892863
• MDR Text Key: 217958814
• Report Number: 3005099803-2020-05649
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/23/2020

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: 10/12/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000045394
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention