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

Model Number M0068505000

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

Patient Problems Fatigue (1849); Muscle Weakness (1967); Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Other: health (b)(6) incident report reference no.(b)(4); submitted to health (b)(6) by the patient.(b)(4).The device was 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 system - halo was implanted into the patient during a procedure performed on (b)(6) 2017.On (b)(6) 2018, the patient experienced chronic fatigue, pain and sore in the hip, upper thigh, back and pelvic floor, and had difficulty in walking.Furthermore, the pain radiates from the pelvis down to the knee and all of the patient's flesh in this region was hurting.Also, the patient could no longer tolerate a simple massage or even lie on her side.Reportedly, the patient could not walk for more than 20 to 30 minutes after her legs would loss its strength, and the side effects experienced got worse over time.

• 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): 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: 12155493
• MDR Text Key: 261302456
• Report Number: 3005099803-2021-03351
• 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: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2021

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: 11/16/2019
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0000048733
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability