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

BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068505000

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Vomiting (2144); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Weight Changes (2607); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 06/27/2017

Event Type Injury

Event Description

Manufacturer Narrative

Date of event: the date of event was approximated to (b)(6) 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representative.The implant surgeon is dr.(b)(6).(b)(4).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.

Manufacturer Narrative

Additional information to blocks b5, d6b: explant date, e1 (lawyer, firm, healthcare facility), and h6.Block b3 date of event: the date of event was approximated to june 27, 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d6b explant date: there was no information available regarding the exact explant date.However, it was reported that the patient underwent mesh sling removal on (b)(6) 2021.Therefore, (b)(6), 2021 has been selected as the explant date.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(6) united states.(b)(6).Telephone no: (b)(6).Fax no: (b)(6).Block h6: patient codes e2006, e2330, e0123, e1002, e2326, e1714, e02020, and e020202 capture the reportable events of extrusion (erosion of the vaginal mesh), pain (low back pain, tailbone and vaginal pain, left sij pain, left hip pain, low back pain, painful joints, muscle aches), nerve damage (pudendal neuralgia), pain, abdominal, inflammation (sacroiliitis), rash (rash/hives related to mesh), anxiety, and depression, respectively.Impact codes f1903, f1905, f2202, and f2303 capture the reportable events of device explantation (mesh sling removal), device revision or replacement (transobturator tape (tot) mesh trim, vaginal defect repair, repair erosion of mesh, anterior posterior repair), endoscopic procedure -egd test (esophagogastroduodenoscopy), and medication required (pudendal nerve block, left sacroiliac joint injection), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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

Manufacturer Narrative

Block b3 date of event: the date of event was approximated to june 27, 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d6b explant date: there was no information available regarding the exact explant date.However, it was reported that the patient underwent mesh sling removal on (b)(6) 2021.Therefore, (b)(6) 2021 has been selected as the explant date.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Telephone no: (b)(6).Fax no: (b)(6).Block h6: patient codes e2006, e2330, e0123, e1002, e2326, e1714, e02020, and e020202 capture the reportable events of extrusion (erosion of the vaginal mesh), pain (low back pain, tailbone and vaginal pain, left sij pain, left hip pain, low back pain, painful joints, muscle aches), nerve damage (pudendal neuralgia), pain, abdominal, inflammation (sacroiliitis), rash (rash/hives related to mesh), anxiety, and depression, respectively.Impact codes f1903, f1905, and f2303 capture the reportable events of device explantation (mesh sling removal), device revision or replacement (transobturator tape (tot) mesh trim, vaginal defect repair, repair erosion of mesh, anterior posterior repair), and medication required (pudendal nerve block, left sacroiliac joint injection), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The removed mesh 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.

Manufacturer Narrative

Block b3 date of event: the date of event was approximated to (b)(6) 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d6b explant date: there was no information available regarding the exact explant date.However, it was reported that the patient underwent mesh sling removal on (b)(6) 2021.Therefore, (b)(6) 2021 has been selected as the explant date.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Block h6: patient codes e2006, e2330, e0123, e1002, e2326, e1714, e02020, and e020202 capture the reportable events of extrusion (erosion of the vaginal mesh), pain (low back pain, tailbone and vaginal pain, left sij pain, left hip pain, low back pain, painful joints, muscle aches), nerve damage (pudendal neuralgia), pain, abdominal, inflammation (sacroiliitis), rash (rash/hives related to mesh), anxiety, and depression, respectively.Impact codes f1903, f1905, and f2303 capture the reportable events of device explantation (mesh sling removal), device revision or replacement (transobturator tape (tot) mesh trim, vaginal defect repair, repair erosion of mesh, anterior posterior repair), and medication required (pudendal nerve block, left sacroiliac joint injection), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.Block h11: blocks b5, b7, h6 and h10 have been updated based on the additional information received on september 27, 2022.Block h6: patient code e1401 was utilized to capture the event of vaginal discharge.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a transobturator tension-free tape, urethropexy, hysterectomy, and cystoscopy procedure performed on (b)(6) 2015, for the treatment of stress urinary incontinence and overactive bladder.Examination under anesthesia revealed that the patient had minimal cystocele and rectocele present.The procedure was uneventful.Cystoscopy results revealed a normal bladder with normal bilateral ureteral openings.Furthermore, the patient had a total blood loss of 20 ml and she received ancef as a prophylactic antibiotic.Also, pneumatic boots were used during surgery.Additionally, the patient had a complete hysterectomy in 2016.On june 27, 2017, the patient underwent transobturator tape (tot) mesh trim and vaginal defect repair for the treatment of vaginal mesh erosion.The patient had a small defect in the mid-vaginal area where a few fibers of the mesh were felt.As the patient had been symptomatic, she was brought in for excision of the eroded mesh.The midline mesh was trimmed, and fibers removed.More of the vaginal mucosa was released.The vaginal mucosa was then approximated to the remaining mesh with a 2-0 vicryl suture.Moreover, complete hemostasis was maintained.The patient withstood the procedure very well and was transferred to recovery in stable condition.In (b)(6) 2020, the patient had anterior posterior repair.She also underwent egd tests (esophagogastroduodenoscopy) in (b)(6) 2020 and (b)(6) 2021.The patient then underwent mesh sling removal in (b)(6) 2021.On (b)(6) 2022, the patient had a follow-up visit.She was post right pudendal nerve block and reported that she was experiencing more than 80 to 90% ongoing relief.The patient had low back pain with a score of 10 out of 10 and described this pain as achy.Furthermore, the patient reported that walking and sitting for long periods of time had increased the pain.She mentioned that changing positions and using lidocaine patches helped alleviate this pain.Additionally, the patient had tailbone and vaginal pain.The patient had mentioned that she was taking medications from outside providers as prescribed.Medications were helping her with function and activities of daily living (adls).The patient had discussed with her physician taking out the arms of the sling that was implanted in the patient.She had a right pudendal nerve block on the right side that helped with tailbone pain on the right side but not the vaginal discomfort.She had left sij pain and pain in the left hip area.The patient experienced rash/hives related to mesh as noted in the past medical history of the medical records.Additionally, the following were also noted as past medical history without a date of onset: abdominal pain, nausea, vomiting, diarrhea, constipation, and sexual functioning/intercourse difficulties, cyst on her breast, colon polyps, depression, anxiety, hypertension, high cholesterol, and weight gain.During the review of systems, the patient indicated she has joint stiffness, muscle aches, painful joints, and weakness.Furthermore, she had difficulty swallowing, loss of strength, low back pain, sleep disturbance/insomnia, depressed mood, and neck pain.Exam revealed neck stiffness and crepitation, pain with flexion, extension and rotation of the head, limited range of motion, poor posture of cervical spine and rounded shoulders; the patient's back was tender to palpation over lumbar-sacral spine, left sacroiliac joint tenderness, pain elicited with rotation of the trunk, extension, and flexion; decreased left upper extremity strength 4/5, left medial nerve injury with supination/pronation pain and limitations, bilateral forearm scars due to motor vehicle accident, and left ankle decreased rom 3/5 strength.Based on the physical exam and clinical findings, the assessment was sacroiliitis and pudendal neuralgia.The patient was to be scheduled for a left pudendal nerve block as the patient wanted to move forward with this injection.She also considered a left sacroiliac joint injection.Additional information received on (b)(6) 2022.On (b)(6) 2021, the patient was experiencing vaginal pain.The patient had a history of vaginal discharge.Reportedly, the patient was still experiencing vaginal pain, itching and some discharge.On the physician's examination, she had palpable tenderness but there was no active erosion in the office.In the operating room the physician did an exam under anesthesia and found 2 areas of erythema and granulation tissue which was likely secondary to mesh exposure.Patient desired complete removal of vaginal mesh.She was consented regarding risks, benefits, alternatives, of this management.No guarantees were implied or made.Patient willingly signed consent for surgery.Findings include bilateral ureteral jets, no sutures, mesh, masses, or abnormalities in bladder.Two areas in the anterior wall of the vagina with erythema and granulation tissue.Mesh resection in right and left periurethral tunnel.No injury to ureters, urethra, bladder.The patient was taken the operating room where general anesthesia was found to be adequate.Patient was prepped and draped in normal sterile fashion in dorsal lithotomy position in allen stirrups.Careful attention was paid not to hyperextend or hyperflex the knees and the hips.Timeout was conducted, and appropriate patient was verified.The physician first began by performing an ultrasound to evaluate for vaginal mesh.This was done with the assistance of the radiology technicians taking pictures.The physician then used a 30-degree cystoscope and placed a guidewire in the right and left ureteral stents.The physician then placed a ureteral catheter over this guidewire to about 15 cm in length.The cystoscope was removed and the foley catheter was placed.A lone star self-retaining retractor was used to improve optimization of the anterior vaginal wall.The physician then infiltrated the periurethral tunnels in the mid urethra with 20 cc of ropivacaine.The physician then made an incision in a horizontal fashion and was able to visualize the permanent material.This was grasped using a tonsil clamp and using sharp dissection i carefully dissected the mesh off the periurethral side first and then off the vaginal side second.Once this was done, the physician then went to the patient's right side and performed a similar procedure.The physician was able to grasp the mesh towards the pubic ramus and cut using mayo scissors.The physician then copiously irrigated the incision and performed a cystoscopy again.Bilateral ureteral jets were visualized and no abnormalities noted on the urethra.The stents were removed under direct visualization.The foley catheter was replaced.The physician then closed the vaginal incision in interrupted fashion after placing gelfoam within both tunnels.The bladder was retrograde filled with 100 cc of fluid and the foley was completely removed.No packing was placed.All needle counts and laparotomy sponge counts were correct x2.Patient was taken the pacu extubated in stable condition.On (b)(6) 2021, the patient was seen and examined for a post operative follow up following the mesh removal procedure.The patient was doing well and felt like everything was better.An estrace cream and pain control medications were prescribed.Upon examination, the patient had vaginal spotting.The patient reportedly voids spontaneously at regular intervals.No urine leakage was noted.The patient has not yet resumed performing intercourse.Additional information received on (b)(6) 2022.On (b)(6) 2021, the patient was seen and examined for psychological evaluation for a chronic pain condition, depression and insomnia per patient request.The total interview time was 30 minutes.The patient reported having 14 years of education and was not working.The patient's occupation was speedway cashier.Her last date of employment was one year ago.The patient's pain was due to a vaginal sling implanted in 2015 with resulting vaginal pain and right leg pain.She also reported all over body pain for many years such as neck and arm pain.She noted car accidents contributed to pain.The patient has underwent surgeries on arms after an accident for her pain problem.Patient has underwent trigger points, rfa's interventional pain procedures for her pain problem.The procedures were temporarily effective with her pain.Medical history includes hypertension, high cholesterol, and gerd.The patient reported walking too long and physical activity increased her pain.She reported interventional procedures to decrease the pain.Over time, her pain has increased.She reported that stress increased her pain and pain can cause stress.Her current pain was at 6 on a 1-10 scale with 10 being the worst pain imaginable.The lowest patient reported her pain was at a 4, while the worst was at a 10.The patient reported having no significant other.Patient's family was somewhat supportive.Patient spent a typical day sitting at home, resting, and did some light chores and errands.Reported psychiatric history includes psychiatric evaluation and counseling for work stressors, depression and anxiety.She recently saw a psychiatrist and has an appointment with another facility at the end of the month.Patient reported taking effexor which she started for road rage years ago but recently restarted it for stress.She reported a family history of no mental illness.Current life stressors were relationship breakup.She felt like she was used and was having difficulty getting over it.She noted a pattern of feeling used.She was quite tangential during the appointment and noted difficulty staying focused.Current sleep pattern included difficulty staying asleep due to the pain and sleeping four hours.She has tried melatonin, trazodone, hydroxyzine, zanaflex and klonopin in the past and noted the insomnia since around 2016.The patient reported depressive symptoms such as sad, down and irritability.The patient reported anxiety symptoms such as worry.Patient reported history of relationship abuse, the last time in 2019.She also reported history of three car accidents, being hit by a car as a child, and being struck by lightning as a child.She denied ptso symptoms.Patient reported no psychotic symptoms.The patient denied any suicidal ideation.There was no suicidal history.The patient denied any homicidal ideation.Patient appeared to be oriented to person, place and time.Patient's memory, concentration, and judgment appeared to be within normal limits for a person of her age and education.Patient reported difficulties on tasks involving concentration.Patient appeared to have the ability to understand her current medical condition.Controlled substances taken reportedly include none.Alcohol use reportedly included a drink on occasion.She reported she used to drink six beers and day but stopped in 2019.Illegal drug use reportedly included none.She admitted to nightly marijuana use until 2019.She reported a history of two duls.She denied history with drug problems.Patient currently denied smoking.In the physician's assessment, according to the pal, patient's testing was valid.Testing indicated somatic problems such as a tendency to have psychological factors exacerbate patient's physical symptoms, present with multiple vague physical complaints and be preoccupied with health status and physical concerns.Testing indicated no anxiety symptoms.Testing indicated anxiety related disorders such as focus on traumatic events that continue to cause stress having left the patient changed in some way.Testing indicated depressive symptoms such as thoughts of worthlessness, hopelessness as well as problems concentrating, feelings of sadness and loss of interest in normal activities, low energy, lethargy, sleep disturbance and changes in appetite.No symptoms of mania were found.Testing indicated paranoid symptoms such as tendency to hold grudges and blame others for any misfortunes.Testing indicated schizophrenic-type traits such as confusion, concentration problems and disorganized thought processes.Testing indicated borderline personality traits such as uncertainty of life, feelings of emptiness, lack of fulfillment and absence of purpose and history of intense relationships in which patient has felt exploited and betrayed.No antisocial traits were found.There were no indicators of alcohol problems found.There were no indicators of drug problems found.No aggressive tendencies were found.There were no indications of suicidal tendencies.There was some indication of lack of social support.There was no indication of a poor psychological treatment response.The patient's patterns of response on the test indicated mild trend with problems disclosing personal information, mild trend with presenting self in an overly favorable light and mild trend with being overly harsh in own self-evaluation.Negative health habits included eating and inactivity.With regards to psychiatric status, patient's responses indicated no symptoms of anxiety, such as feeling of tension and worry.Testing found no symptoms of depression, such as feelings of sadness and worthlessness.There were mild symptoms of cognitive dysfunction, such as difficulty with memory and concentration.There were mild symptoms of emotional lability such as mood swings.There were no indicators of guardedness from patient.With regards to stress indicators, the physician found no symptoms of worry about patient's illness.The patient was not overly focused on their functional impairments.There were no indicators that the patient was overly focused on her pain.There was no indication of social isolation with the patient.There was no indication of pessimism about the future of her medical condition.With regards to treatment prognoses, the physician indicated the patient had no symptoms of having difficulty tolerating invasive medical interventional procedures.There were no indicators for a potential for medication abuse.There was some indication that patient has difficulty tolerating too much information about her medical condition.There was no indication that patient tends to over utilize medical services.There was no indication that patient has difficulty complying with medical instructions.The physician indicated patient had no problems adjusting to her current medical condition.A psychiatric referral was not recommended for patient.According to the multidimensional pain inventory, patient's pain coping style was somewhat dysfunctional.The patient was reporting very severe pain.The pain was somewhat interfering with the patient's life.The patient felt she has no control over her pain.She was experiencing some distress related to the pain.There was a moderate effect on patient's general activity level due to pain.According to the pain anxiety symptoms scale, patient was experiencing no significant overall anxiety related to the pain.According to the perceived disability scale patient fell within the average of patients with spinal cord injuries.It needs to be noted patient perceived self as disabled as someone in a wheel chair.According to the cesd patient fell within the range of severe depression.According to the health locus of control patient felt she has some control over her health.Psychological testing and evaluation services by psychologist including interpretation, integration, clinical decision making, and treatment planning was 236 minutes (4 units).Psychological testing and scoring by technician was 120 minutes (4 units).Psychological test scoring by the technician and interpretation and integration by the psychologist was completed in lexington, ky as that was the doctor's primary office location.In the physician's assessment, the patient was experiencing major depressive disorder, single episode, moderate and pain disorder with related psychological factors.Conclusions and recommendations of the physician include the patient meeting the criteria for major depression indicating she was moderately down and sad the majority of the time.She noted mood was influence by pain and some current life stressors.Patient meets the criteria for pain disorder associated with both psychological factors and a general medical condition.Pain was negatively impacting mood, sleep, and daily activities.She has been referred for psychiatric treatment for depression and has an appointment with another healthcare facility at the end of the month.For convenience and coordination of care, it was also recommended that she receive individual psychotherapy focusing on depression and coping with current life stressors unrelated to her medical condition.She was currently prescribed effexor.She can return as needed for behavioral medicine treatment for her pain condition, focusing on relaxation strategies, cognitive behavioral pain coping strategies and possibly cognitive behavioral strategies for insomnia.From a psychological perspective, patient appeared to be able to tolerate interventional pain procedures at this time.On (b)(6) 2021, the patient was seen and examined for pelvic/groin, tailbone and right thigh pain.She reported that this pain was constant, stabbing and throbbing.This pain started following pelvic surgery and the creation of pelvic sling.She scored this pain a 10/10 nrs at its worst.She stated that any prolonged positioning exacerbates this pain.She scored this pain an 8/10 nrs at its best.Patient admitted to neck pain and was scheduled for a right cervical medial branch block on (b)(6) 2021.Patient reported that taking diclofenac was helpful in moderating her cervical pain.Patient reported no other changes to health history or medications.She reported that she saw her physician yesterday and was awaiting the reports from the physician visit regarding possible cbt.Based on the physical exam and clinical findings, the patient's chief complaint was consistent with pelvic pain and coccydynia.They will schedule an impar ganglion block for continuation of pain management.In the physician's assessment, the patient was experiencing cervical spondylosis without myelopathy and pelvic pain.A follow up after four weeks was scheduled for right impar ganglion nerve block.

Manufacturer Narrative

Block b3 date of event: the date of event was approximated to (b)(6) 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d6b explant date: there was no information available regarding the exact explant date.However, it was reported that the patient underwent mesh sling removal on (b)(6) 2021.Therefore, september 1, 2021 has been selected as the explant date.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(6).(b)(6) telephone no: (b)(6).Fax no: (b)(6).Block h6: patient codes e2006, e2330, e0123, e1002, e2326, e1714, e02020, and e020202 capture the reportable events of extrusion (erosion of the vaginal mesh), pain (low back pain, tailbone and vaginal pain, left sij pain, left hip pain, low back pain, painful joints, muscle aches), nerve damage (pudendal neuralgia), pain, abdominal, inflammation (sacroiliitis), rash (rash/hives related to mesh), anxiety, and depression, respectively.Impact codes f1903, f1905, and f2303 capture the reportable events of device explantation (mesh sling removal), device revision or replacement (transobturator tape (tot) mesh trim, vaginal defect repair, repair erosion of mesh, anterior posterior repair), and medication required (pudendal nerve block, left sacroiliac joint injection), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.Block h11: blocks b5, b7, h6 and h10 have been updated based on the additional information received on (b)(6) 2022.Block h6: patient code (b)(6) was utilized to capture the event of vaginal discharge.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on (b)(6), 2022.Block h6: patient code e0206 captures the reportable event of unspecified mental, emotional or behavioral problem.

Manufacturer Narrative

Blocks b5 was updated based on the additional information received on february 21, 2023.Block b3 date of event: the date of event was approximated to june 27, 2017, the date when the patient had an excision of vaginal mesh, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d6b explant date: there was no information available regarding the exact explant date.However, it was reported that the patient underwent mesh sling removal in september 2021.Therefore, (b)(6) 2021, has been selected as the explant date.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Block h6: imdrf patient codes: e2006 captures the reportable event of extrusion (erosion of the vaginal mesh).E2330 captures the reportable event of pain (low back pain, tailbone and vaginal pain, left sij pain, left hip pain, low back pain, painful joints, muscle aches).E0123 captures the reportable event of nerve damage (pudendal neuralgia).E1002 captures the reportable event of pain, abdominal.E2326 captures the reportable event of inflammation (sacroiliitis).E1714 captures the reportable event of rash (rash/hives related to mesh).E02020 captures the reportable event of anxiety.E020202 captures the reportable event of depression.E1401 captures the reportable event of vaginal discharge.E0206 captures the reportable event of unspecified mental, emotional or behavioral problem.Imdrf impact codes: f1903 captures the reportable event of device explantation (mesh sling removal).F1905 captures the reportable event of device revision or replacement (transobturator tape (tot) mesh trim, vaginal defect repair, repair erosion of mesh, anterior posterior repair).F2303 captures the reportable event of medication required (pudendal nerve block, left sacroiliac joint injection).

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a transobturator tension-free tape, urethropexy, hysterectomy, and cystoscopy procedure performed on (b)(6), 2015, for the treatment of stress urinary incontinence and overactive bladder.Examination under anesthesia revealed that the patient had minimal cystocele and rectocele present.The procedure was uneventful.Cystoscopy results revealed a normal bladder with normal bilateral ureteral openings.Furthermore, the patient had a total blood loss of 20 ml and she received ancef as a prophylactic antibiotic.Also, pneumatic boots were used during surgery.Additionally, the patient had a complete hysterectomy in 2016.On (b)(6) 2017, the patient underwent transobturator tape (tot) mesh trim and vaginal defect repair for the treatment of vaginal mesh erosion.The patient had a small defect in the mid-vaginal area where a few fibers of the mesh were felt.As the patient had been symptomatic, she was brought in for excision of the eroded mesh.The midline mesh was trimmed, and fibers removed.More of the vaginal mucosa was released.The vaginal mucosa was then approximated to the remaining mesh with a 2-0 vicryl suture.Moreover, complete hemostasis was maintained.The patient withstood the procedure very well and was transferred to recovery in stable condition.In (b)(6) 2020, the patient had anterior posterior repair.She also underwent egd tests (esophagogastroduodenoscopy) in july 2020 and july 2021.The patient then underwent mesh sling removal in september 2021.On (b)(6), 2022, the patient had a follow-up visit.She was post right pudendal nerve block and reported that she was experiencing more than 80 to 90% ongoing relief.The patient had low back pain with a score of 10 out of 10 and described this pain as achy.Furthermore, the patient reported that walking and sitting for long periods of time had increased the pain.She mentioned that changing positions and using lidocaine patches helped alleviate this pain.Additionally, the patient had tailbone and vaginal pain.The patient had mentioned that she was taking medications from outside providers as prescribed.Medications were helping her with function and activities of daily living (adls).The patient had discussed with her physician taking out the arms of the sling that was implanted in the patient.She had a right pudendal nerve block on the right side that helped with tailbone pain on the right side but not the vaginal discomfort.She had left sij pain and pain in the left hip area.The patient experienced rash/hives related to mesh as noted in the past medical history of the medical records.Additionally, the following were also noted as past medical history without a date of onset: abdominal pain, nausea, vomiting, diarrhea, constipation, and sexual functioning/intercourse difficulties, cyst on her breast, colon polyps, depression, anxiety, hypertension, high cholesterol, and weight gain.During the review of systems, the patient indicated she has joint stiffness, muscle aches, painful joints, and weakness.Furthermore, she had difficulty swallowing, loss of strength, low back pain, sleep disturbance/insomnia, depressed mood, and neck pain.Exam revealed neck stiffness and crepitation, pain with flexion, extension and rotation of the head, limited range of motion, poor posture of cervical spine and rounded shoulders; the patient's back was tender to palpation over lumbar-sacral spine, left sacroiliac joint tenderness, pain elicited with rotation of the trunk, extension, and flexion; decreased left upper extremity strength 4/5, left medial nerve injury with supination/pronation pain and limitations, bilateral forearm scars due to motor vehicle accident, and left ankle decreased rom 3/5 strength.Based on the physical exam and clinical findings, the assessment was sacroiliitis and pudendal neuralgia.The patient was to be scheduled for a left pudendal nerve block as the patient wanted to move forward with this injection.She also considered a left sacroiliac joint injection.Additional information received on september 27, 2022.On (b)(6), 2021, the patient was experiencing vaginal pain.The patient had a history of vaginal discharge.Reportedly, the patient was still experiencing vaginal pain, itching and some discharge.On the physician's examination, she had palpable tenderness but there was no active erosion in the office.In the operating room the physician did an exam under anesthesia and found 2 areas of erythema and granulation tissue which was likely secondary to mesh exposure.Patient desired complete removal of vaginal mesh.She was consented regarding risks, benefits, alternatives, of this management.No guarantees were implied or made.Patient willingly signed consent for surgery.Findings include bilateral ureteral jets, no sutures, mesh, masses, or abnormalities in bladder.Two areas in the anterior wall of the vagina with erythema and granulation tissue.Mesh resection in right and left periurethral tunnel.No injury to ureters, urethra, bladder.The patient was taken the operating room where general anesthesia was found to be adequate.Patient was prepped and draped in normal sterile fashion in dorsal lithotomy position in allen stirrups.Careful attention was paid not to hyperextend or hyperflex the knees and the hips.Timeout was conducted, and appropriate patient was verified.The physician first began by performing an ultrasound to evaluate for vaginal mesh.This was done with the assistance of the radiology technicians taking pictures.The physician then used a 30-degree cystoscope and placed a guidewire in the right and left ureteral stents.The physician then placed a ureteral catheter over this guidewire to about 15 cm in length.The cystoscope was removed and the foley catheter was placed.A lone star self-retaining retractor was used to improve optimization of the anterior vaginal wall.The physician then infiltrated the periurethral tunnels in the mid urethra with 20 cc of ropivacaine.The physician then made an incision in a horizontal fashion and was able to visualize the permanent material.This was grasped using a tonsil clamp and using sharp dissection i carefully dissected the mesh off the periurethral side first and then off the vaginal side second.Once this was done, the physician then went to the patient's right side and performed a similar procedure.The physician was able to grasp the mesh towards the pubic ramus and cut using mayo scissors.The physician then copiously irrigated the incision and performed a cystoscopy again.Bilateral ureteral jets were visualized and no abnormalities noted on the urethra.The stents were removed under direct visualization.The foley catheter was replaced.The physician then closed the vaginal incision in interrupted fashion after placing gelfoam within both tunnels.The bladder was retrograde filled with 100 cc of fluid and the foley was completely removed.No packing was placed.All needle counts and laparotomy sponge counts were correct x2.Patient was taken the pacu extubated in stable condition.On (b)(6) 2021, the patient was seen and examined for a post operative follow up following the mesh removal procedure.The patient was doing well and felt like everything was better.An estrace cream and pain control medications were prescribed.Upon examination, the patient had vaginal spotting.The patient reportedly voids spontaneously at regular intervals.No urine leakage was noted.The patient has not yet resumed performing intercourse.Additional information received on october 24, 2022.On (b)(6), 2021, the patient was seen and examined for psychological evaluation for a chronic pain condition, depression and insomnia per patient request.The total interview time was 30 minutes.The patient reported having 14 years of education and was not working.The patient's occupation was speedway cashier.Her last date of employment was one year ago.The patient's pain was due to a vaginal sling implanted in 2015 with resulting vaginal pain and right leg pain.She also reported all over body pain for many years such as neck and arm pain.She noted car accidents contributed to pain.The patient has underwent surgeries on arms after an accident for her pain problem.Patient has underwent trigger points, rfa's interventional pain procedures for her pain problem.The procedures were temporarily effective with her pain.Medical history includes hypertension, high cholesterol, and gerd.The patient reported walking too long and physical activity increased her pain.She reported interventional procedures to decrease the pain.Over time, her pain has increased.She reported that stress increased her pain and pain can cause stress.Her current pain was at 6 on a 1-10 scale with 10 being the worst pain imaginable.The lowest patient reported her pain was at a 4, while the worst was at a 10.The patient reported having no significant other.Patient's family was somewhat supportive.Patient spent a typical day sitting at home, resting, and did some light chores and errands.Reported psychiatric history includes psychiatric evaluation and counseling for work stressors, depression and anxiety.She recently saw a psychiatrist and has an appointment with another facility at the end of the month.Patient reported taking effexor which she started for road rage years ago but recently restarted it for stress.She reported a family history of no mental illness.Current life stressors were relationship breakup.She felt like she was used and was having difficulty getting over it.She noted a pattern of feeling used.She was quite tangential during the appointment and noted difficulty staying focused.Current sleep pattern included difficulty staying asleep due to the pain and sleeping four hours.She has tried melatonin, trazodone, hydroxyzine, zanaflex and klonopin in the past and noted the insomnia since around 2016.The patient reported depressive symptoms such as sad, down and irritability.The patient reported anxiety symptoms such as worry.Patient reported history of relationship abuse, the last time in 2019.She also reported history of three car accidents, being hit by a car as a child, and being struck by lightning as a child.She denied ptso symptoms.Patient reported no psychotic symptoms.The patient denied any suicidal ideation.There was no suicidal history.The patient denied any homicidal ideation.Patient appeared to be oriented to person, place and time.Patient's memory, concentration, and judgment appeared to be within normal limits for a person of her age and education.Patient reported difficulties on tasks involving concentration.Patient appeared to have the ability to understand her current medical condition.Controlled substances taken reportedly include none.Alcohol use reportedly included a drink on occasion.She reported she used to drink six beers and day but stopped in 2019.Illegal drug use reportedly included none.She admitted to nightly marijuana use until 2019.She reported a history of two duls.She denied history with drug problems.Patient currently denied smoking.In the physician's assessment, according to the pal, patient's testing was valid.Testing indicated somatic problems such as a tendency to have psychological factors exacerbate patient's physical symptoms, present with multiple vague physical complaints and be preoccupied with health status and physical concerns.Testing indicated no anxiety symptoms.Testing indicated anxiety related disorders such as focus on traumatic events that continue to cause stress having left the patient changed in some way.Testing indicated depressive symptoms such as thoughts of worthlessness, hopelessness as well as problems concentrating, feelings of sadness and loss of interest in normal activities, low energy, lethargy, sleep disturbance and changes in appetite.No symptoms of mania were found.Testing indicated paranoid symptoms such as tendency to hold grudges and blame others for any misfortunes.Testing indicated schizophrenic-type traits such as confusion, concentration problems and disorganized thought processes.Testing indicated borderline personality traits such as uncertainty of life, feelings of emptiness, lack of fulfillment and absence of purpose and history of intense relationships in which patient has felt exploited and betrayed.No antisocial traits were found.There were no indicators of alcohol problems found.There were no indicators of drug problems found.No aggressive tendencies were found.There were no indications of suicidal tendencies.There was some indication of lack of social support.There was no indication of a poor psychological treatment response.The patient's patterns of response on the test indicated mild trend with problems disclosing personal information, mild trend with presenting self in an overly favorable light and mild trend with being overly harsh in own self-evaluation.Negative health habits included eating and inactivity.With regards to psychiatric status, patient's responses indicated no symptoms of anxiety, such as feeling of tension and worry.Testing found no symptoms of depression, such as feelings of sadness and worthlessness.There were mild symptoms of cognitive dysfunction, such as difficulty with memory and concentration.There were mild symptoms of emotional lability such as mood swings.There were no indicators of guardedness from patient.With regards to stress indicators, the physician found no symptoms of worry about patient's illness.The patient was not overly focused on their functional impairments.There were no indicators that the patient was overly focused on her pain.There was no indication of social isolation with the patient.There was no indication of pessimism about the future of her medical condition.With regards to treatment prognoses, the physician indicated the patient had no symptoms of having difficulty tolerating invasive medical interventional procedures.There were no indicators for a potential for medication abuse.There was some indication that patient has difficulty tolerating too much information about her medical condition.There was no indication that patient tends to over utilize medical services.There was no indication that patient has difficulty complying with medical instructions.The physician indicated patient had no problems adjusting to her current medical condition.A psychiatric referral was not recommended for patient.According to the multidimensional pain inventory, patient's pain coping style was somewhat dysfunctional.The patient was reporting very severe pain.The pain was somewhat interfering with the patient's life.The patient felt she has no control over her pain.She was experiencing some distress related to the pain.There was a moderate effect on patient's general activity level due to pain.According to the pain anxiety symptoms scale, patient was experiencing no significant overall anxiety related to the pain.According to the perceived disability scale patient fell within the average of patients with spinal cord injuries.It needs to be noted patient perceived self as disabled as someone in a wheel chair.According to the cesd patient fell within the range of severe depression.According to the health locus of control patient felt she has some control over her health.Psychological testing and evaluation services by psychologist including interpretation, integration, clinical decision making, and treatment planning was 236 minutes (4 units).Psychological testing and scoring by technician was 120 minutes (4 units).Psychological test scoring by the technician and interpretation and integration by the psychologist was completed in lexington, ky as that was the doctor's primary office location.In the physician's assessment, the patient was experiencing major depressive disorder, single episode, moderate and pain disorder with related psychological factors.Conclusions and recommendations of the physician include the patient meeting the criteria for major depression indicating she was moderately down and sad the majority of the time.She noted mood was influence by pain and some current life stressors.Patient meets the criteria for pain disorder associated with both psychological factors and a general medical condition.Pain was negatively impacting mood, sleep, and daily activities.She has been referred for psychiatric treatment for depression and has an appointment with another healthcare facility at the end of the month.For convenience and coordination of care, it was also recommended that she receive individual psychotherapy focusing on depression and coping with current life stressors unrelated to her medical condition.She was currently prescribed effexor.She can return as needed for behavioral medicine treatment for her pain condition, focusing on relaxation strategies, cognitive behavioral pain coping strategies and possibly cognitive behavioral strategies for insomnia.From a psychological perspective, patient appeared to be able to tolerate interventional pain procedures at this time.On (b)(6), 2021, the patient was seen and examined for pelvic/groin, tailbone and right thigh pain.She reported that this pain was constant, stabbing and throbbing.This pain started following pelvic surgery and the creation of pelvic sling.She scored this pain a 10/10 nrs at its worst.She stated that any prolonged positioning exacerbates this pain.She scored this pain an 8/10 nrs at its best.Patient admitted to neck pain and was scheduled for a right cervical medial branch block on (b)(6), 2021.Patient reported that taking diclofenac was helpful in moderating her cervical pain.Patient reported no other changes to health history or medications.She reported that she saw her physician yesterday and was awaiting the reports from the physician visit regarding possible cbt.Based on the physical exam and clinical findings, the patient's chief complaint was consistent with pelvic pain and coccydynia.They will schedule an impar ganglion block for continuation of pain management.In the physician's assessment, the patient was experiencing cervical spondylosis without myelopathy and pelvic pain.A follow up after four weeks was scheduled for right impar ganglion nerve block.Additional information received on february 21, 2023.On (b)(6), 2021, the patient presented with depression and anxiety.She had an initial psychiatric appointment and evaluation.The patient had undergone pain management.She had a vaginal sling implanted and multiple procedures related to it.The patient experienced pain and an itching problem.She still has to have another surgery to get the sling completely removed.Additionally, the patient has chronic gastrointestinal problems, and she had imaging studies in august.Furthermore, the patient also had problems with sleep due to pain.She had taken ambien and stated that it worked but was taken off.She did take trazodone 50mg qhs in the past.The patient tried remeron with an increased appetite.Also, she tried melatonin and took up to 150 mg of benadryl to try to sleep.Currently, the patient has been getting nerve block injections for pain.The patient had motor vehicle crash (mvc) in 1992 and started on pain management then initially.She had multiple fractures and required orthopedic surgeries in both arms.She stated that she had suffered 3 concussions in her life: 2 in childhood and 2 in car accidents.The patient has anxiety about her pain, changes in function, and vaginal itching.She thought that she had nerve damage.She has had a pudendal nerve block.In an interview, she stated that she has always had problems with anxiety.Sometimes she struggles to focus due to worry.Pain seemed to exacerbate this problem.The patient stated that if she's home, she's depressed.However, if she's busy and not thinking about it, she does not feel depressed.The patient denied 2-week periods consistent with depressive episodes.She had more transient problems than this, and she never struggled with suicidal thoughts.Additionally, the patient presented for an initial evaluation for long-term anxiety.The patient's anxiety symptoms were most consistent with generalized anxiety disorder (gad).She does have transient symptoms of depression that are most consistent with adjustment disorder.It does not appear to have had sufficient depressive symptoms to meet the criteria for mdd (major depressive disorder).She does have long-term pain issues that lead to trouble sleeping.She has had some medication trials.The patient has a history of traumatic events but is not currently suffering from active ptsd symptoms.The physician recommended full trial of another ssri at this point, given the side effects of effexor, which were muscle twitches, and the patient's limited improvement on duloxetine.She was recently prescribed bupropion, but the physician recommended she hold off on this for now due to predominant anxiety.The patient will trial lexapro after weaning from effexor.She will have a follow-up after one month.She had tried low doses of trazodone for sleep, and she would be okay with a trial at 100mg to see if this helps.The patient opted to not do this for now.Moreover, the patient had chronic pain problems, was single, and recently quit her job as a lead cashier at speedway because of the shooting nerve pain in the arm.She's unsure if she will get a better job, waiting to see how procedures go with her vaginal sling.The patient lives by herself in a condo that she rented.She lives in section 8 housing.Her hobbies were limited; she used to like art and drawing.She had a bad recent dating experience in which her ex-boyfriend attempted suicide and would not get mental health treatment.The patient does have a history of sexual assault in her teenage years.Also, she had a bad car accident.She does have sporadic nightmares.She had no problems with driving or avoiding.The patient has no intrusive thoughts or issues worth reminding her of.She was able to have sexual encounters without being reminded of the event.

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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

14626921

MDR Text Key

294136657

Report Number

3005099803-2022-02996

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718987

UDI-Public

08714729718987

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K040787

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

06/07/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Model Number

M0068505000

Device Catalogue Number

850-500

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

02/21/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

59 YR

Patient Sex

Female

Patient Race

White

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

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