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

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

Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Depression (2361); Disability (2371); Numbness (2415); No Code Available (3191)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by a healthcare professional/user.The complaint device 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 a boston scientific obtryx sling was implanted into the patient during a prolapse colpopexy vaginal repair, cystocele and rectocele procedures performed on (b)(6) 2016.According to the patient, right after the implantation, there was a pain in the right leg and could not be moved for 48 hours.Towards the end of the year, the patient has suffered mesh erosion.In (b)(6) 2016, the patient had a second surgery and it caused pudendal neuralgia and further mesh erosion.The patient has also suffered pain with sitting, standing and walking.Pain in the tailbone, lower back, rectal and perineum, genital numbness and tingling.It was less painful after bowel movement but the pain magnifies if the patient was constipated.Vulva area was bright red and less painful with no underwear.The pain throbs if sitting too long or standing.The patient has also experienced disabilities; could not go for a walk and unable to work.Additionally, the patient was taking panadol, tramadol, lyrica during the night and panadiene forte every 4 hours during the day.Boston scientific has been unable to obtain additional information regarding the event.

• 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: 10898925
• MDR Text Key: 218235761
• Report Number: 3005099803-2020-05667
• 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,foreig
• Type of Report: Initial
• Report Date: 11/24/2020

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: 05/01/2017
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention