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 Adhesion(s) (1695); Erosion (1750); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 02/09/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2021 to treat a patient with mixed urinary incontinence and opted for repeat sling placement.Findings from the examination under anesthesia showed no adnexal masses.Cystoscopy findings presented normal-appearing urethra and bladder, with no injury.Also, bilateral ureteral jets were noted.On an unspecified date, the patient presented to the office with complaints of being able to feel vaginal mesh after suburethral sling was placed.On (b)(6) 2021, the patient underwent excision of vaginal mesh for the preoperative diagnosis of vaginal mesh exposure.Exam under anesthesia revealed approximately 0.5cm of exposed mesh on the left side of the patient's urethra.During the procedure, mesh was grasped with pickups and trimmed back below the mucosa.There was scant blood loss noted.Moreover, no mesh could be palpated after the excision.The patient tolerated the procedure well.She was taken in awake and stable condition to the post- anesthesia care unit (pacu).Reportedly, a small portion of vaginal mesh was sent for pathology.The patient claimed to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product(s): obturator neuralgia; pelvic pain; dyspareunia; vaginal pain; urinary issues; erosion; and chronic complications of mesh, including inflammation and foreign body reaction as well as the need for multiple surgical revisions.The patient's medical needs were ongoing, so this list is subject to change as her condition develops and diagnoses are received in the future.The patient also claimed to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product(s): past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, the date when the patient underwent transobturator tape procedure, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).(b)(4).

Event Description

Note: this report pertains to one of two devices used with the same patient.It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2021 to treat a patient with mixed urinary incontinence and opted for repeat sling placement.Findings from the examination under anesthesia showed no adnexal masses.Cystoscopy findings presented normal-appearing urethra and bladder, with no injury.Also, bilateral ureteral jets were noted.On an unspecified date, the patient presented to the office with complaints of being able to feel vaginal mesh after suburethral sling was placed.On (b)(6) 2021, the patient underwent excision of vaginal mesh for the preoperative diagnosis of vaginal mesh exposure.Exam under anesthesia revealed approximately 0.5cm of exposed mesh on the left side of the patient's urethra.During the procedure, mesh was grasped with pickups and trimmed back below the mucosa.There was scant blood loss noted.Moreover, no mesh could be palpated after the excision.The patient tolerated the procedure well.She was taken in awake and stable condition to the post- anesthesia care unit (pacu).Reportedly, a small portion of vaginal mesh was sent for pathology.The patient claimed to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product(s): obturator neuralgia; pelvic pain; dyspareunia; vaginal pain; urinary issues; erosion; and chronic complications of mesh, including inflammation and foreign body reaction as well as the need for multiple surgical revisions.The patient's medical needs were ongoing, so this list is subject to change as her condition develops and diagnoses are received in the future.The patient also claimed to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product(s): past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.On (b)(6) 2022, the patient was seen and examined.Preoperative and post operative diagnosis include obturator neuralgia, vaginal pain, and pudendal neuralgia.The patient underwent a transvaginal tvt-o mesh excision and bilateral groin exploration with tvt-o mesh excision.Findings include a single strip of vaginal mesh was identified and excised.Two strips of mesh in each groin were identified and excised.During the procedure, the urethral sling was identified.It was blue.The patient had a history of having had 2 tvt-o slings placed.She had a mesh erosion and reports a history of a partial resection of 1 of the slings.As it turns out after thorough dissection up under the pubic ramus bilaterally, only the 1 sling could be identified consistent with the prior sling that was eroded having been removed from the vaginal compartment.The physician undermined the remaining sling and separated it from the urethra, divided it in the midline, and dissected it out as far laterally as possible bilaterally up under the bone.The patient's right side with tension, the sling came away completely.On the patient's left side, this was left attached where it was felt to be tightly adherent up under the pubic bone.The physician then proceeded with the groin dissections.They started on the patient's left side.They made an incision starting just below the insertion of the adductor longus muscle.Incision was approximately 4 cm long, carried through the dissection to the subcutaneous fat and fascia for the adductor muscles.They cut through a very small amount of the gracilis muscle and was able to identify 2 segments of sling, again both blue in color consistent with the tvt-o groin mesh components.The distal end was identified and both pieces of mesh were grasped with a kocher clamp using predominantly sharp dissection.They then carried the dissection down through the muscle all the way up to the level of the obturator membrane.One piece of mesh came away from the membrane intact.This was consistent with the mesh that had already been resected from the vaginal compartment.The other piece of mesh eventually was able to be separated from the bone with traction and blunt dissection digital.They then applied traction to the vaginal portion of the mesh in an attempt to take the piece out intact.This snapped off at the level of the bone.That piece again was saved for pathology.With further traction on the groin component, the mesh came away completely intact consistent with complete excision of the mesh from the vagina on the left and the groin compartment.They then proceeded with the same dissection on the patient's right side, again made an incision in the groin just below the level of the insertion of the adductor longus muscle.Once again, 2 pieces of mesh were relatively easily identified.The terminal portions were identified, freed, and then grasped with a kocher clamp in the same way they had done on the contralateral side.The mesh was dissected sharply back to the level of the obturator membrane and using traction and a combination of blunt and sharp dissection both pieces of mesh came away intact consistent with complete excision of the mesh from the right groin as well.They then closed the incisions.They started with the vaginal component.They trimmed a minimal amount of excess vaginal mucosa.They then performed a paravaginal defect repair bilaterally, which had been created from the dissection, reapproximating the fascia of the bladder toward the midline with the endopelvic fascia laterally with a series of interrupted #0 vicryl sutures.Per the physician, this very effectively repaired the defects.They then closed the vagina using sutures.The patient was brought to the recovery room awake, alert, in apparent stable condition.There were no complications reported at the conclusion of the procedure.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to february 09, 2021, the date when the patient underwent transobturator tape procedure, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Phone number: (b)(6).Block h6: patient code e1311 captures the reportable event of "urinary problems." patient code e0206 captures the reportable event of "unspecified mental, emotional or behavioural problems." patient code e2330 captures the reportable event of "vaginal and pelvic pain and obturator neuralgia." patient code e0402 captures the reportable event of "foreign body reaction." patient code e2006 captures the reportable event of "erosion." patient code e0123 captures the reportable event of "obturator neuralgia." patient code e1405 captures the reportable event of "dyspareunia." patient code e2326 captures the reportable event of "inflammation." impact code f1905: device revision or replacement has been used to capture the reportable events of transobturator tape procedure, and excision of vaginal mesh procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block h6 and h10 have been corrected based on the medical review received on january 17, 2023.Block h6: patient code e1311 captures the reportable event of "urinary problems." patient code e0206 captures the reportable event of "unspecified mental, emotional or behavioural problems." patient code e2330 captures the reportable event of "vaginal and pelvic pain and obturator neuralgia." patient code e0402 captures the reportable event of "foreign body reaction." patient code e2006 captures the reportable event of "erosion" and "extrusion." patient code e0123 captures the reportable event of "obturator neuralgia." patient code e1405 captures the reportable event of "dyspareunia." patient code e2326 captures the reportable event of "inflammation." impact code f1905: device revision or replacement has been used to capture the reportable events of transobturator tape procedure, and excision of vaginal mesh procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, b7, h6 and h10 have been updated based on the additional information received on february 27, 2023 and march 10, 2023.Block h6: patient code e1311 captures the reportable event of "urinary problems." patient code e0206 captures the reportable event of "unspecified mental, emotional or behavioural problems." patient code e2330 captures the reportable event of "vaginal and pelvic pain and obturator neuralgia." patient code e0402 captures the reportable event of "foreign body reaction." patient code e2006 captures the reportable event of "erosion" and "extrusion." patient code e0123 captures the reportable event of "obturator neuralgia." patient code e1405 captures the reportable event of "dyspareunia." patient code e2326 captures the reportable event of "inflammation." patient code e2101 captures the reportable event of "adhesions." impact code f1905: device revision or replacement has been used to capture the reportable events of transobturator tape procedure, and excision of vaginal mesh procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2021, the date when the patient underwent transobturator tape procedure, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Dr.(b)(6).(b)(6).Block h6: patient code e1311 captures the reportable event of "urinary problems." patient code e0206 captures the reportable event of "unspecified mental, emotional or behavioural problems." patient code e2330 captures the reportable event of "vaginal and pelvic pain and obturator neuralgia." patient code e0402 captures the reportable event of "foreign body reaction." patient code e2006 captures the reportable event of "erosion." patient code e0123 captures the reportable event of "obturator neuralgia." patient code e1405 captures the reportable event of "dyspareunia." patient code e2326 captures the reportable event of "inflammation." impact code f1905: device revision or replacement has been used to capture the reportable events of transobturator tape procedure, and excision of vaginal mesh procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2021 to treat a patient with mixed urinary incontinence and opted for repeat sling placement.Findings from the examination under anesthesia showed no adnexal masses.Cystoscopy findings presented normal-appearing urethra and bladder, with no injury.Also, bilateral ureteral jets were noted.On an unspecified date, the patient presented to the office with complaints of being able to feel vaginal mesh after suburethral sling was placed.On (b)(6) 2021, the patient underwent excision of vaginal mesh for the preoperative diagnosis of vaginal mesh exposure.Exam under anesthesia revealed approximately 0.5cm of exposed mesh on the left side of the patient's urethra.During the procedure, mesh was grasped with pickups and trimmed back below the mucosa.There was scant blood loss noted.Moreover, no mesh could be palpated after the excision.The patient tolerated the procedure well.She was taken in awake and stable condition to the post- anesthesia care unit (pacu).Reportedly, a small portion of vaginal mesh was sent for pathology.The patient claimed to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product(s): obturator neuralgia; pelvic pain; dyspareunia; vaginal pain; urinary issues; erosion; and chronic complications of mesh, including inflammation and foreign body reaction as well as the need for multiple surgical revisions.The patient's medical needs were ongoing, so this list is subject to change as her condition develops and diagnoses are received in the future.The patient also claimed to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product(s): past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.

Event Description

Note: this report pertains to one of two devices used with the same patient.Please refer to mfr report 3005099803-2022-03100 for the associated device.It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2021 to treat a patient with mixed urinary incontinence and opted for repeat sling placement.Findings from the examination under anesthesia showed no adnexal masses.Cystoscopy findings presented normal-appearing urethra and bladder, with no injury.Also, bilateral ureteral jets were noted.On an unspecified date, the patient presented to the office with complaints of being able to feel vaginal mesh after suburethral sling was placed.On (b)(6) 2021, the patient underwent excision of vaginal mesh for the preoperative diagnosis of vaginal mesh exposure.Exam under anesthesia revealed approximately 0.5cm of exposed mesh on the left side of the patient's urethra.During the procedure, mesh was grasped with pickups and trimmed back below the mucosa.There was scant blood loss noted.Moreover, no mesh could be palpated after the excision.The patient tolerated the procedure well.She was taken in awake and stable condition to the post- anesthesia care unit (pacu).Reportedly, a small portion of vaginal mesh was sent for pathology.The patient claimed to have suffered the following injuries as a result of the implantation of the prior designated pelvic mesh product(s): obturator neuralgia; pelvic pain; dyspareunia; vaginal pain; urinary issues; erosion; and chronic complications of mesh, including inflammation and foreign body reaction as well as the need for multiple surgical revisions.The patient's medical needs were ongoing, so this list is subject to change as her condition develops and diagnoses are received in the future.The patient also claimed to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh product(s): past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on february 27, 2023 and march 10, 2023.Patient history: at the conclusion of the transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2018, the patient tolerated the procedure well.On (b)(6) 2022, the patient was seen and examined.Preoperative and post operative diagnosis include, obturator neuralgia, vaginal pain, and pudendal neuralgia.The patient underwent a transvaginal tvt-o mesh excision and bilateral groin exploration with tvt-o mesh excision.Findings include a single strip of vaginal mesh was identified and excised.Two strips of mesh in each groin was identified and excised.During the procedure, the urethral sling was identified.It was blue.The patient had a history of having had 2 tvt-o slings placed.She had a mesh erosion and reports a history of a partial resection of 1 of the slings.As it turns out after thorough dissection up under the pubic ramus bilaterally, only the 1 sling could be identified consistent with the prior sling that was eroded having been removed from the vaginal compartment.The physician undermined the remaining sling and separated it from the urethra, divided it in the midline, and dissected it out as far laterally as possible bilaterally up under the bone.The patient's right side with tension, the sling came away completely.On the patient's left side, this was left attached where it was felt to be tightly adherent up under the pubic bone.The physician then proceeded with the groin dissections.They started on the patient's left side.They made an incision starting just below the insertion of the adductor longus muscle.Incision was approximately 4 cm long, carried through the dissection to the subcutaneous fat and fascia for the adductor muscles.They cut through a very small amount of the gracilis muscle and was able to identify 2 segments of sling, again both blue in color consistent with the tvt-o groin mesh components.The distal end was identified and both pieces of mesh were grasped with a kocher clamp using predominantly sharp dissection.They then carried the dissection down through the muscle all the way up to the level of the obturator membrane.One piece of mesh came away from the membrane intact.This was consistent with the mesh that had already been resected from the vaginal compartment.The other piece of mesh eventually was able to be separated from the bone with traction and blunt dissection digital.They then applied traction to the vaginal portion of the mesh in an attempt to take the piece out intact.This snapped off at the level of the bone.That piece again was saved for pathology.With further traction on the groin component, the mesh came away completely intact consistent with complete excision of the mesh from the vagina on the left and the groin compartment.They then proceeded with the same dissection on the patient's right side, again made an incision in the groin just below the level of the insertion of the adductor longus muscle.Once again, 2 pieces of mesh were relatively easily identified.The terminal portions were identified, freed, and then grasped with a kocher clamp in the same way they had done on the contralateral side.The mesh was dissected sharply back to the level of the obturator membrane and using traction and a combination of blunt and sharp dissection both pieces of mesh came away intact consistent with complete excision of the mesh from the right groin as well.They then closed the incisions.They started with the vaginal component.They trimmed a minimal amount of excess vaginal mucosa.They then performed a paravaginal defect repair bilaterally, which had been created from the dissection, reapproximating the fascia of the bladder toward the midline with the endopelvic fascia laterally with a series of interrupted #0 vicryl sutures.Per the physician, this very effectively repaired the defects.They then closed the vagina using sutures.The patient was brought to the recovery room awake, alert, in apparent stable condition.There were no complications reported at the conclusion of the procedure.Additional information was received on august 9, 2023.The patient, with a two-month history of genuine stress urinary incontinence, underwent an unsuccessful burch procedure, followed by a transobturator sling placement.According to the patient, she slipped and felt a pop on her right side, and her stress incontinence is starting to come back.During her visit on (b)(6) 2021, it was found that she had a grade 1 rectocele and cystocele.Her uterus is absent, and no mesh exposure was noted.The physician also discussed the patient's medication, collagen injections, or repeat sling procedures.On (b)(6) 2021, the patient complained of frequent pelvic cramping and pressure, back pain and discomfort on the right side of the pelvis, and nagging pains with a 6/10 scale, which can be alleviated by some heating pads and rest.The patient was initially prescribed narcotic medication, but she states she is allergic.She also states that she still feels some urgency.The patient also complained of some nausea, which was alleviated by dramamine.On (b)(6) 2021, the patient reported experiencing a 4/10 level of pain in her right hip.She has occasional urinary urgency and experiences leakage only when she is unable to reach the bathroom in time.She denies any burning or bleeding.The patient also mentions sporadic cramping and denies having a fever.She has felt some nausea but has not vomited.On (b)(6) 2021, the patient experienced painful intercourse following surgery.She claims that there is something hard inside her vagina that is quite painful.Her partner also states that something is not right, and he can sense it when they try to have intercourse.Furthermore, the patient and her partner believe her mesh is protruding.During her physical assessment, a mesh exposure was discovered.On (b)(6) 2021, the patient's pelvic and hip pain persisted.The doctor addressed her options for chronic pelvic pain, and she was advised to see her primary care physician for a workup for slow recovery from procedures.On (b)(6) 2022, present for the evaluation of pain possibly consistent with obturator and/or pudendal neuralgia.According to the report, the patient developed mesh erosion in (b)(6) 2021 and had a small piece trimmed.The patient notes continued pain complaints.She notes some sciatic-type symptoms, especially those involving her right leg.She also notes medial thigh pain, which is greater on the right than on the left.Sex is mildly uncomfortable, but she gets crampy pain afterward.Minimal stress urinary incontinence with some urinary urgency and frequency was also noted.The patient has also had irritable bowel-type symptoms since having the mesh placed.The patient also notes some other systemic symptoms, such as intermittent fevers and fatigue.She denies any vaginal bleeding or abnormal discharge.Moreover, the physician discussed the various mechanisms by which patients with mesh can cause symptoms.Some people do get a chronic inflammatory response, giving them systemic flu-like symptoms.They also discussed the fixation of tissue in the vagina as a cause of pain as well as the possible involvement of neurologic structures such as the obturator and pudendal nerve.Certainly, the patient's medial thigh pain is consistent with obturator nerve pain.According to the physician, the most logical step in treatment is a complete mesh excision, including the groin components.Should the patient develop significant recurrent stress incontinence, this would have to be dealt with another surgery.Surgical risks such as bleeding, infection, and damage to other internal organs, especially the bladder and urethra, were reviewed.Also, the difficulties in extracting the groin mesh, which is sometimes unsuccessful, were reviewed.Physical exam: bimanual: the mesh is readily palpable and tender to palpation, especially on the right side of the mucosa.Impression: the patient has vaginal pain as well as obturator nerve complaints, with some possible pudendal nerve findings as well.The patient also appears to have systemic symptoms from the mesh.On (b)(6) 2022, the patient underwent a transvaginal mesh excision with bilateral groin exploration and mesh excision to address mesh erosion and obturator neuralgia.Following the procedure, the patient was sore but felt that some of her nerve pain complaints were reduced by the surgery.Her vital signs are stable, and the patient is afebrile.On (b)(6) 2022, the patient was status post transvaginal mesh excision with bilateral groin dissection and mesh excision on (b)(6) 2022.The patient presents for her routine postop check.She was overall doing well and noted a significant reduction in her preoperative pain complaints.She does note some stress incontinence with urgency.She states that the vaginal bleeding has greatly decreased.She has moved her bowels without difficulty.She denies any fever or chills.Physical examination: external genitalia: both groin incisions are dry and intact with no erythema or induration, extensive ecchymosis in her medial thighs.Bimanual: the suture line from the mesh excision with cystocele repair is mildly tender to palpation, with no masses palpated.On (b)(6) 2022, the patient presented to the clinic due to chronic back and leg pain from a bladder sling.The patient was advised to continue taking gabapentin 800 mg four times a day.The patient had a telemedicine session on (b)(6) 2022, to discuss her progress and surgery.The patient appeared to be satisfied with the progression of her condition, according to the report.For the first time in years, she can wear jeans.Her overall pain problems have greatly improved.However, she still has sciatica-like symptoms in her right leg, as well as pins and needles in her foot.The doctor explained to the patient that this was most likely a separate condition.The patient reports urinary urgency and leaking, and they've talked about medical treatment for an overactive bladder.Furthermore, mybertriq 25 mg was prescribed to the patient on a daily basis.On (b)(6) 2023, the patient reported a loss of interest and enjoyment.She lacks motivation and energy.She also claims hypersomnia and difficulty concentrating.However, she denies the thoughts of hopelessness or powerlessness and describes some sentiments of worthlessness and guilt.The patient also experiences anxiety and panic attacks.She reports some irritation and restlessness.She also has shoulder muscular tension.

Manufacturer Narrative

Block h2: additional information blocks b5 (event description), b7 (other relevant history) and h6 (patient and impact codes) has been updated based on the additional information received on august 9, 2023.Block b3 date of event: date of event was approximated to february 09, 2021, the date when the patient underwent transobturator tape procedure, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: imdrf patient code e1311 captures the reportable event of "urinary problems." imdrf patient code e0206 captures the reportable event of "unspecified mental, emotional or behavioural problems." imdrf patient code e2330 captures the reportable event of "vaginal and pelvic pain and obturator neuralgia." imdrf patient code e0402 captures the reportable event of "foreign body reaction." imdrf patient code e2006 captures the reportable event of "erosion and vaginal mesh exposure." imdrf patient code e0123 captures the reportable event of "obturator neuralgia." imdrf patient code e1405 captures the reportable event of "dyspareunia." imdrf patient code e2326 captures the reportable event of "inflammation." imdrf patient code e2101 captures the reportable event of "adhesions." imdrf patient code e1405 captures the reportable event of "dyspareunia." imdrf patient code e020201 captures the reportable event of "anxiety." imdrf patient code e0130 captures the reportable event of "hypersomnia." imdrf patient code e020202 captures the reportable event of "depression." imdrf patient code e2401 captures the reportable event of "irritable bowel syndrome." imdrf patient code e0506 captures the reportable event of "vaginal bleeding." the following imdrf impact codes capture the reportable events of: imdrf impact code f1905: device revision or replacement has been used to capture the reportable events of transobturator tape procedure, and excision of vaginal mesh procedure.Imdrf impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Imdrf impact code f2303 has been used to capture the reportable event of patient was prescribed with gabapentin to address overactive bladder.

• 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: 16103690
• MDR Text Key: 306719956
• Report Number: 3005099803-2023-00002
• 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,Followup,Followup,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0026230945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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; Other
• Patient Age: 44 YR
• Patient Sex: Female