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

Model Number	M0068504000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Muscle Weakness/Atrophy (1967); Pain (1994); Burning Sensation (2146); Urinary Frequency / Polyuria (2275); Prolapse (2475); Sleep Dysfunction (2517); Constipation (3274); Balance Problems (4401); Fecal Incontinence (4571); Urinary Incontinence (4572)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1705 captures the reportable event of radiating burns.Imdrf impact code f19 captures the reportable event of the device being explanted.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - curved device was implanted during a procedure performed on (b)(6) 2016.It was noted that the pain was felt in the abdomen, genitals, groin, lower back, perineum, and thighs.Additionally, symptoms of burning sensation, sleep problems, fatigue, loss of balance, muscle weakness, pollakiuria, urinary and fecal leakages, constipation, and prolapse were reported.It was indicated that the patient presented difficulties during prolonged walking, prolonged sitting, and during certain movements such as practicing sports, or during intimate relationships.Therefore, the patient noted their daily life had been compromised.It was detailed that an explant date was performed on may 05, 2021.Boston scientific has been unable to obtain additional information regarding the device location and patient outcome to date.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19101471
• Report Number: 2124215-2024-22422
• Device Sequence Number: 18044121
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/12/2024

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: 05/17/2019
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0000031402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown