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

Model Number UNK-P-OBTRYX/LYNX_SLINGS

Device Problem Material Deformation (2976)

Patient Problems Airway Obstruction (1699); Dysphagia/ Odynophagia (1815); Edema (1820); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Nausea (1970); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Injury (2348); Confusion/ Disorientation (2553); Weight Changes (2607); Constipation (3274)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The voluntary user medwatch number is mw5079072.

Event Description

It was reported to boston scientific corporation that an obtryx sling was implanted during a procedure performed on (b)(6) 2008.Reportedly, symptoms post mesh implant were the following: initial frequent urinary tract infection (uti), painful sexual intercourse, brain fog, fatigue, joint pain, difficulty swallowing (choking on liquids and thin foods), pain around ribs wrapping around the chest, pelvic pain, pelvic floor congestion (abdominal swelling), hair loss.Also, urinary leaking related to post void residual rectal pressure, stool leakage, constipation, vaginal odor.Thirty (30) pounds of excess fluid in the body, 1+ pitting edema to the legs, feet, body, left sacro iliac pain and throbbing were also noted.Elevated autoimmune laboratory results and calcium, low vitamin d, constant nausea, loss of appetite, weakness, gum retraction (exposing the nerves), renal cell carcinoma were also noted.On (b)(6) 2018 , the bladder sling and pelvic mesh were partially removed.The mesh was saved at the pathology department of the patient's attorney.According to the complainant, the mesh was shrunk, hardened and curved into an arc which allegedly caused the patient's pelvic pain.3 weeks post removal, the patient was noted to be pain free and most of the symptoms were gone but she continued to have fluid retention.According to the complainant, the following symptoms were relieved post surgery: fatigue, nausea, constipation, urinary incontinence, rectal pressure, stool leakage and brain fog.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: OBTRYX 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: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7881929
• MDR Text Key: 120448191
• Report Number: 3005099803-2018-60449
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 09/17/2018

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 Model Number: UNK-P-OBTRYX/LYNX_SLINGS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/17/2018
• 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