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

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Pain (1994); Burning Sensation (2146); Discomfort (2330); Numbness (2415); Sleep Dysfunction (2517); Constipation (3274); Movement Disorder (4412); Paresthesia (4421)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during a transobturator tape (tot) procedure performed on (b)(6) 2021.After the procedure, the patient complained of right thigh pain, groin pain, sciatic leg pain, hip pain, buttock pain, and lower back pain.She has difficulty sitting or standing for too long, walking, getting in and out of the car, and climbing the stairs.She has a tingling sensation in her leg and a burning sensation in the buttock, thigh, and lower back.She limps whenever she gets out of the car.She has a blocked hip and pelvis sensation.She has pain and discomfort in her lower right belly and has right groin sensitivity.The patient can no longer feel her straight leg and foot due to feeling numb.She has difficulty sleeping because the position on one side is complicated; there is stab-like pain in her hip and buttocks.She has fatigue and frequent constipation.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2021, implant date, as no event date was reported.Block h6: imdrf patient code e2303 captures the reportable event of pain.Imdrf patient code f1202 captures the reportable event of difficulty sitting or standing for too long, walking, getting in and out of the car, and climbing the stairs.

• Brand Name: OBTRYX SYSTEM - HALO
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18838886
• Report Number: 2124215-2024-12252
• Device Sequence Number: 12574242
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026111361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown