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

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

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Nerve Damage (1979); Pain (1994); Discomfort (2330); Prolapse (2475); Sleep Dysfunction (2517); Paresthesia (4421); Suicidal Ideation (4429); Dyspareunia (4505)

Event Date 09/24/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system was implanted to the patient on a procedure performed on (b)(6) 2017.After implantation, the patient is in everyday pain.She cannot stand, has trouble walking, and needs a stick.The mesh has ruined her sexual life and her ability to stand, walk, and sleep.She is on endless bleeding and gets very restless as she cannot sleep since she finds it hard to be comfortable.Has incontinence and prolapse in her vagina.Daily life is unbearable; sometimes she feels like ending it all.The pain is consuming her life, and she is on painkillers, creams, and pillows.She feels throbbing electric shocks that go down to her inner thighs and has been in constant, uncomfortable, tight pain ever since the mesh, obtryx ii system, was implanted.A few days after the procedure, tightness, prickles, and throbbing were present.Vaginal bleeding was noted.A needle-like sensation could be felt inside her pelvis and hips.Years later, the pain became worse and could be felt on a daily basis, making her life a miserable one.

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h5: imdrf patient code e2330 captures the reportable event of patient in constant pain.Imdrf patient code e1405 captures the reportable event of painful sexual intercourse.Imdrf patient code e0123 captures the reportable event of needle-like feeling inside the pelvis and hips.Imdrf impact code f1202 captures the reportable event of difficulty walking and standing.

• Brand Name: OBTRYX II SYSTEM
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18346822
• MDR Text Key: 330808264
• Report Number: 2124215-2023-70464
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other