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

Model Number M0068505000

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

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Discomfort (2330); Numbness (2415); Dysuria (2684); Movement Disorder (4412); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Heart Problem (4454); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/07/2022

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the second of the two devices used during different procedures.Refer to manufacturer report number 3005099803-2023-02659 for the first obtryx system - halo device.It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during an anterior and posterior colporrhaphy + bilateral sacrospinous fixation + vaginal revision of the previously implanted obtryx + obtryx sling implant procedure performed on (b)(6) 2021 due to the complications of the previous obtryx sling.After the procedure, the plaintiff had experienced significant medical and physical pain and suffering, permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures.Had suffered and will continue to suffer serious bodily injuries, including pain, discomfort, pressure, difficulty voiding urine, continued incontinence, discharge, scarring, infection, odor, bleeding, chronic pain from nerve injury, serious physical and mental injuries, disability, and other losses.On (b)(6) 2022, the plaintiff presented with right groin pain, left groin pain, spontaneous orgasm, numbness sensation around her clitoris and anus.Examination noted incredibly significant tenderness and spasm of the pelvic floor muscles bilaterally with extreme tenderness with palpating medial to the left ischial spine in the area corresponding with the left pudendal nerve and hypersensitivity to touch of bilateral labia majora and clitoris and hypersensitivity to touch and palpation of the right adductor muscles.She was also diagnosed with obturator neuralgia, pudendal neuralgia, complex regional pain syndrome ii, spontaneous orgasms, dyspareunia, and spastic pelvic floor as complications from previously implanted obtryx devices with a plan of care that includes the following: removal of groin mesh bilaterally (2 pieces of obtryx mesh in each groin) removal of vaginal sling (1 complete obtryx, one partially removed) bilateral pudendal nerve block botox into pelvic floor muscles (400 units) bulkamed urethral bulking agent.Her refractory symptoms of neurological pain and myofascial pain including groin pain was caused in part by the obtryx sling implanted on (b)(6) 2018 until sometime after the (b)(6) 2021 implantation of the second obtryx sling.Following the implantation of these obtryx devices, plaintiff has been diagnosed with debilitating pain, impairments including difficulty walking and loss of rectal control, groin pain, obturator and pudendal neuralgia, loss of sexual function due to severe dyspareunia, spontaneous orgasm, complex regional pain syndrome, spastic pelvic floor syndrome, chronic pelvic pain, chronic groin pain, and other complications and symptoms.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date the patient was diagnosed with the symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient codes e2330, e1405, e1301, e2311, e1715, e232401, e2401, e0122, e0123, e1605, e1906 and e0206 capture the reportable events of pain; dyspareunia; dysuria; discomfort; scarring; loss of rectal control; impairments including difficulty walking, spontaneous orgasm and other complications and symptoms; obturator and pudendal neuralgia and nerved injury; spastic pelvic floor syndrome; infection; and mental injuries.Imdrf impact codes f1204 and f1202 capture the reportable events of permanent injury and disability.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of september 7, 2022 was chosen as a best estimate based on the date the patient was diagnosed with the symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Imdrf patient codes e2330, e1405, e1301, e2311, e1715, e232401, e2401, e0122, e0123, e1605, e1906 and e0206 capture the reportable events of pain; dyspareunia; dysuria; discomfort; scarring; loss of rectal control; impairments including difficulty walking, spontaneous orgasm and other complications and symptoms; obturator and pudendal neuralgia and nerved injury; spastic pelvic floor syndrome; infection; and mental injuries.Imdrf impact codes f1204 and f1202 capture the reportable events of permanent injury and disability.Block h6 patient code has been corrected.(ar-p code 9209: palpitations/e0623: unspecified heart problem has been removed.The reported event of "palpating medial to the left ischial spine; palpation of the right adductor muscles" is referring to examination of these areas and not heart palpitations.).

Event Description

Note: this manufacturer report pertains to the second of the two devices used during different procedures.Refer to manufacturer report number 3005099803-2023-02659 for the first obtryx system - halo device.It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during an anterior and posterior colporrhaphy + bilateral sacrospinous fixation + vaginal revision of the previously implanted obtryx + obtryx sling implant procedure performed on (b)(6) 2021 due to the complications of the previous obtryx sling.After the procedure, the plaintiff had experienced significant medical and physical pain and suffering, permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures.Had suffered and will continue to suffer serious bodily injuries, including pain, discomfort, pressure, difficulty voiding urine, continued incontinence, discharge, scarring, infection, odor, bleeding, chronic pain from nerve injury, serious physical and mental injuries, disability, and other losses.On september 7, 2022, the plaintiff presented with right groin pain, left groin pain, spontaneous orgasm, numbness sensation around her clitoris and anus.Examination noted incredibly significant tenderness and spasm of the pelvic floor muscles bilaterally with extreme tenderness with palpating medial to the left ischial spine in the area corresponding with the left pudendal nerve and hypersensitivity to touch of bilateral labia majora and clitoris and hypersensitivity to touch and palpation of the right adductor muscles.She was also diagnosed with obturator neuralgia, pudendal neuralgia, complex regional pain syndrome ii, spontaneous orgasms, dyspareunia, and spastic pelvic floor as complications from previously implanted obtryx devices with a plan of care that includes the following: - removal of groin mesh bilaterally (2 pieces of obtryx mesh in each groin) - removal of vaginal sling (1 complete obtryx, one partially removed) - bilatrel pudendal nerve block - botox into pelvic floor muscles (400 units) - bulkamed urethral bulking agent.Her refractory symptoms of neurological pain and myofascial pain including groin pain was caused in part by the obtryx sling implanted on (b)(6) 2018 until sometime after the (b)(6), 2021 implantation of the second obtryx sling.Following the implantation of these obtryx devices, plaintiff has been diagnosed with debilitating pain, impairments including difficulty walking and loss of rectal control, groin pain, obturator and pudendal neuralgia, loss of sexual function due to severe dyspareunia, spontaneous orgasm, complex regional pain syndrome, spastic pelvic floor syndrome, chronic pelvic pain, chronic groin pain, and other complications and symptoms.

• Brand Name: OBTRYX 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: 16956642
• MDR Text Key: 315531998
• Report Number: 3005099803-2023-02660
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026864307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female