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

Model Number M0068505110

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6) health.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - used to capture the reported event of erosion.E1311 - used to capture the reported event of bladder dysfunction.E0206 - used to capture the reported event of significant mental suffering.E2330 - used to capture the reported event of leg pain, perineal pain, pelvic pain, bladder pain, vaginal pain, anorectal pain, and complex regional pain syndrome.E1310 - used to capture the reported event of urinary tract infection.E0123 - used to capture the reported event of pudendal neuralgia and obturator neuralgia.E1405 - used to capture the reported event of painful intercourse.E2326 - used to capture the reported event of interstitial cystitis.E2401 - used to capture the reported events of bowel dysfunction, pelvic floor tension myalgia and hip adductor myalgia.The following imdrf impact codes capture the reportable events of: f19 - used to capture the reported event of patient sought treatment of the reported events.F1202 - used to capture the reported event of patient has sustained permanent injury.

Event Description

It was reported to boston scientific corporation that an obtryx ii system halo device was implanted into the patient during a procedure performed on (b)(6) 2021, for the treatment of pelvic organ prolapse.Reportedly, the aftermath of the procedure was complicated post-surgically with intractable and ongoing post-operative leg, perineal, and pelvic pain.The patient sought treatment on (b)(6) 2023, after months of abdominal and pelvic pain, hip pain, erosion, bladder pain, urinary tract infection, and vaginal pain.For the first time, the patient was informed that removing the solyx sling was a possibility for treating her symptoms.Such revision surgery has not yet been performed on the patient.Additionally, the patient continues to experience problems, including abdominal and pelvic pain, urinary problems, vaginal pain, painful intercourse, erosion, infection, and recurrence of incontinence.The patient continues to require medical care for her painful mesh-related conditions.Furthermore, as a direct and proximate result of having the solyx implanted in her, the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury, which includes or more likely than not may include any of the following: pudendal neuralgia, obturator neuralgia, pelvic floor tension myalgia, hip adductor myalgia, complex regional pain syndrome, erosion, recurrent urinary tract infections, interstitial cystitis, chronic dyspareunia, bowel and bladder dysfunction, and anorectal pain.The patient will likely undergo medical treatment and procedures after suffering financial or economic loss, including, but not limited to, obligations for medical services and expenses, lost income, and other damages.

• Brand Name: OBTRYX II SYSTEM - HALO
• 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: 17122409
• MDR Text Key: 317119285
• Report Number: 3005099803-2023-03002
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0027103469
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female