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

BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068503000

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fall (1848); Fatigue (1849); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Dizziness (2194); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 02/06/2017

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2017 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (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.

Event Description

Manufacturer Narrative

Additional information: blocks a2, b2, b3, b5, b7, d6b and h6.Block b3: date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6) hospital by dr.(b)(6).Block h6: patient codes e2326, e2330, e1310, e0127, e1002, f1903, f2303 capture the reportable event of bladder/back pain, urinary tract infection, paresthesia, abdominal pain mesh removal and medication required.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Correction to blocks b5 and h6: patient codes block b3: date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6).Block h6: the following patient codes capture the reportable events below: e2330 - bladder/back pain e1310 - urinary tract infection e0127 - paresthesia e1002 - abdominal pain e2114 - urethral tear e2015 - reactive arthritis e0402 - allergic reaction to the sling e2101 - adhesions e2313 - fibrosis e2007 - multiple falls e1301 - dysuria e1906 - infection e2101 - adhesions the following impact codes capture the reportable events below: f1903 - mesh removal f2303 - medication required.F1202 - limited activity due to pain.

Event Description

Manufacturer Narrative

Additional information: blocks b2: outcomes attrib to adv event, b5, b7, h6: patient and impact codes correction to block g2: report source block b3: date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at willis-knighton south hospital by dr.Alexander gomelsky.Block h6: the following patient codes capture the reportable events below: e2330 - bladder/back pain e1310 - urinary tract infection e0127 - paresthesia e1002 - abdominal pain e2114 - urethral tear e2015 - reactive arthritis e0402 - allergic reaction to the sling e2101 - adhesions e2313 - fibrosis the following impact codes capture the reportable events below: f1903 - mesh removal f2303 - medication required.F1202 - limited activity due to pain block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Blocks a5, a6, b5, h6: patient codes and h6: impact codes updated based on the additional information received on october 24, 2022.Block b3: date of event: date of event was approximated to february 6, 2017 (first clinic visit post implant) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6).Block h6: 9266: swelling 9111: fatigue 9181: musculoskeletal stiffness or spasm, not stimulation-related.The following patient codes capture the reportable events below: e2330 - bladder/back pain.E1310 - urinary tract infection.E0127 - paresthesia.E1002 - abdominal pain.E2114 - urethral tear.E2015 - reactive arthritis.E0402 - allergic reaction to the sling.E2101 - adhesions.E2313 - fibrosis.E2007 - multiple falls.E1301 - dysuria.E1906 - infection.E2101 - adhesions.E1705 - burning senstion.E1302 - hematuria.E1309 - urinary retention.E2328 - urethral obstruction.E1715 - scar tissue.E1405 - dyspareunia.E1635 - stiffness of joints.E2312 - fatigue.E2338 - swelling the following impact codes capture the reportable events below: f1903 - mesh removal f2303 - medication required.F1202 - limited activity due to pain.F1901 - urethrolysis.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted on january 23, 2017.As reported by the patient's attorney, the patient experienced an unknown injury.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.***additional information received on 19jan2022*** it was reported that the patient had been diagnosed with stress urinary incontinence with an element of uterine prolapse.On january 23, 2017, she underwent a lynx mid-urethral sling placement procedure with cystoscopy and vaginal hysterectomy.Patient tolerated the procedure well with no complications.Patient went for a follow-up visit on (b)(6) 2017 stating she had been doing well and voiding without difficulty.She denies any stress incontinence but is having a small amount of post voiding dribbling after she stands up after urinating.A month later she reported during her 6-week follow-up on (b)(6) 2017 that all of her symptoms have resolved, and she is dry.On (b)(6) 2017, patient reports stating she felt a significant twinge and bladder spasm as she was lifting a box of candied apples three days ago.She had to go to the emergency room due to the incident.She was treated with rocephin and placed on cipro for possible urinary tract infection.No culture was sent, and a dip urine was not available for review.She was still continent and emptying well.On (b)(6) 2019, patient presented for possible mesh infection.She was diagnosed with reactive arthritis and reporting that she has been having problems since after the mesh placement that she thinks is related to her mesh and wanted to undergo mesh removal to hopefully resolve her symptoms.However, multiple ct scans of the abdomen had been performed and did not show any problems on the mesh, no fistula or drainage.Urine cultures in the past did not grow anything except some regular flora.A different physician submitted urine pcr which showed enterococcus faecalis and acinetobacter sensitive to quinolones.She was placed on macrodantin chronically for over a month and was told she was to take it for over a year but was scared of that.She wanted to remain on antibiotics until after the mesh removal procedure.The impression was cystitis.She was prescribed cipro 250 twice a day for two weeks until she has the surgery as well as amoxicillin 875 p.O.B.I.D.For 2 weeks and due to risk of vaginal yeast infection was given diflucan 100 mg p.O.Daily for 2 weeks.Patient was to stop macrodantin.C reactive protein (crp), complete blood count (cbc), and comprehensive metabolic panel were performed.On (b)(6) 2019, patient underwent mesh removal procedure.At the follow-up on (b)(6) 2019, the patient was noted to be doing fine post-removal of the mesh with the wound healing up okay.On (b)(6) 2019, patient presented to a neurology clinic for evaluation of paresthesias in the right leg.She reported that following hysterectomy and mesh placement, she had a complication and infection that required extensive antibiotics.Post mesh placement she has noted pain in the right lower quadrant of the abdomen.Pain appears on straining and continues to happen on and off.She also has noted numbness in her right leg.The numbness is severe in intensity with almost no sensations in the leg.For the last few months, the numbness had appeared about once a week and lasted for half an hour or so; she had fewer episodes of numbness prior to this.Patient has been seeing a rheumatologist for diagnosis of reactive arthritis and undergoing treatments for the same.Additionally, patient has mild and low chronic back pain with radiation on the right side.In the review of systems, the patient indicated she had dysuria, urinary incontinence, rash, back pain, joint pain, muscle weakness, pain radiating down arms/legs, and bruising.The assessment included numbness of the right lower extremity with the exam significant for mild pain in the right calf, right-sided arthritis, and lateral deviation of the right leg; differential diagnoses included lumbar spine pathology or pelvic pathology (e.G.Abscess).The plan was for lumbar spine mri, which if normal, would be followed by pelvis mri.The assessment also included right-sided low back pain with right-sided sciatica, other chronic pain, and bmi of 33.0-33.9.***additional information received on july 18, 2022*** the patient was noted to have developed reaction to the pubovaginal sling with multiple somatic complaints.With removal of the sling in (b)(6) 2019, she developed relatively severe stress incontinence related to sphincter deficiency.The patient was admitted to the hospital on (b)(6) 2019 following harvest of the rectus fascia sheath and pubovaginal sling procedure.During the vaginal portion of the procedure, dense adhesions and fibrosis were noted over the urethra, as expected.The patient had urethral tear as well during the dissection from urethra to endopelvic fascia.Prolene sutures were secured in the suprapubic wounds coapting the sling to the urethra.A vaginal pack was also placed into the wound.After the procedure, the patient was taken from the operating room to the recovery room in stable condition.On (b)(6) 2021, the patient was diagnosed with lumbosacral spondylosis with radiculopathy and chronic pain syndrome.She reported that post implant, she developed the following: right groin pain; reactive arthritis which has caused flares of inflammation all over her body; low back pain with radiating pain down her right leg; and numbness when she goes to sleep.She reported she had about three episodes of not being able to move her right leg and had multiple falls.History of present illness: initial evaluation: (b)(6) 2021.Date of onset: (b)(6) 2021.Concurrent: no concurrent services medical care prior to current episode: mri: spondylotic changes l4-l5 with spinal stenosis, l4-5 disc degeneration with annulus tear and diffuse bulging with central protrusion, injections history of present illness: chronic back pain with recent worsening of symptoms.Illness severity or complexity: chronic pain, mri results.Body part/system being evaluated: lumbar.Reported current functional limitations: 1.Activity intolerance - difficulty prolonged standing, walking.2.Falls - difficulty going up her stairs at home.3.Disturbed sleep every night.Pain assessment: constant low back radiating down to bilateral posterior hips; sometimes radiating down posterior leg to knee.Worse when standing, walking, bending over.Better: "nothing" hot pad, aleve every day.Current: 6/10 average: 6/10 worst: 10/10.Premorbid functional status: chronic back pain x4 years.Work/education/play: limited activity due to her pain.Palpation: tender throughout lumbar spine and hips.Modified oswestry low back pain disability questionnaire: pain intensity: the pain is moderate and does not vary much personal care: washing and dressing increases her pain, and she finds it necessary to change the way she does it.Lifting: she can lift only very light weights.Walking: pain prevents the patient from walking intermediate distances.Sitting: pain prevents her from sitting for more than 1 hour.Standing: she can stand but her pain increases with time.Sleeping: her sleep is only half of her normal amount due to pain.Social life: pain prevents her from going out very often.Traveling: she gets increased pain when traveling, but it does not cause her to seek alternative forms of travel.Employment/homemaking: she can perform most of her job/homemaking duties, but pain prevents her from performing more physically stressful activities (ex.Lifting, vacuuming, etc.).Treatment: no treatment.Assessment/plan: * patient education education provided to patient: home program, plan of care mode of patient education: explanation, demonstration, printed material patient education response: verbal understanding, needs practice/reinforcement * weaknesses chronic and worsening pain.* flags present yellow flags present: depression.* summary of evaluation.Patient presented to physical therapist with diagnosis of lumbosacral spondylosis with radiculopathy.She reported a history of chronic back pain that has worsened and multiple falls.She demonstrated decreased lumbar and left hip rom/flexibility, decreased core stability and decreased right hip strength.She will benefit from pt to address these areas in order to reduce her pain and improve her function/reduce fall risk.Assessment.Rehabilitation potential: patient's condition has potential to improve patient's motivation/commitment to rehab/treatment: good patient's support structure: family/caregiver was willing and able to support patient and participate in his/her rehabilitation plan of care recommended consults: none at this time patient requires a skilled therapy plan: return to premorbid environment.To reduce need for assist with functional activity/adls/mobility.To return to work.To function in community.**additional information received on september 22, 2022: on (b)(6) 2017, the patient complained of pain in pelvis, bladder pain and bladder spasms that began a day ago.She reportedly recovered well after her sling procedure in 2017 until a day ago, she started to experience frequent bladder spasms that were coming every 20 seconds and now she had difficulty passing urine.She rated pain as 7 out of 10, 8 out of 10 when at worst and level that was acceptable was 0 out of 10.She described her pain as burning and sharp.Current medications: antispasmodic.Bladder scan showed 18 ml, and quick catheter was inserted to obtain a urine specimen that was orange-tinged.The patient was administered toradol and rocephin and was discharged home with plans to follow up with her provider.Assessment: pain.Gastrointestinal: the patient reported normal bowel habits.Genitourinary: she reported urinary frequency for 1 day and bladder spasms.On (b)(6) 2018, she reported that she suspected she has some urgency and frequency, but she admitted drinking a lot of fluids during the day and before bedtime.On exam, the patient's suprapubic incisions appeared healed without fluctuance or erythema.All vaginal incisions were intact and there was no leakage with valsalva.There was no evidence of sling extrusion, tenderness, periurethral banding or over correction of the urethral angle.There was some aymptomatic rectocele remaining.Furthermore, her urine test showed small blood.Impression: 1.Patient was pleased as her mixed incontinence resolved after sling surgery.2.Urgency, frequency and nocturia due to high fluid intake.3.Multiple somatic symptoms (weight gain, muscle and joint pain, red eyes, elbow and wrist tendonitis and whole body discomfort) developing acutely approximately 4-5 months ago following a sinus infection and major reaction to medication.Patient was undergoing multiple workups with multiple specialists.Plan: 1.She was to continue her follow-up with her physicians.On (b)(6) 2019, the patient presented for moderate urinary tract infection.Associated symptoms included incomplete bladder emptying, slow stream, urinary urgency, lower abdominal pain and vaginal pain.It was noted during the visit that her pain was improving.Review of systems and physical exam noted normal.Assessment/plan: 1.Acute lower uti.Urinalysis performed during the visit.2.Urge incontinence the patient was scheduled for sling removal, likely vaginal and abdominal approach.On (b)(6) 2019, the patient presented for excision of pubovaginal sling with urethrolysis.Her pre and postoperative diagnoses included pelvic pain and urethral obstruction.During admission for the procedure, she also reported severe dyspareunia, frequency, urgency, and weak stream.Findings: sling appeared to be in good position with no evidence of infection.There was dense scar tissue around the urethra.The sling was cut in the midline at the level of the urethra, dissected laterally on each side and remained intact through the endopelvic fascia and up to the abdominal wall.An abdominal approach was then used to dissect each arm of the sling to the rectus fascia, and the sling was excised completely.After the procedure, the patient was taken to the recovery room in stable condition.On (b)(6) 2019, the patient complained of urinary incontinence.After her mesh removal in january 2019, she developed severe stress incontinence related to sphincter deficiency.The patient was then admitted to the hospital following harvest of the rectus fascia sheath and pubovaginal sling.Assessment: stress incontinence intrinsic sphincter deficiency ***additional information received on october 24, 2022*** on (b)(6) 2018, the patient presented for flexible cystoscopy, which showed normal results.There was no evidence of sling erosion or pelvic organ prolapse.With manipulation and probing, she had moderate tenderness of the mid-urethra as well as reported severe tenderness of the entire posterior vaginal wall.The patient was insistent that the systems were related to the mesh.It was explained that there was no indication of improper or abnormal placement or migration of her sling, and there was no evidence of erosion or extrusion.The patient reported that approximately six months after her mesh implant in january 2017, she has had a myriad of new complaints including abdominal pain.Swelling, bloating.Pelvic pain, utis, scleritis.Joint pain and others.Her test showed negative for uti.Preoperative and postoperative diagnoses were noted as pelvic pain and self-reported utis.On (b)(6) 2020, the patient presented for evaluation of arthralgias in elbows, shoulders, hands and ankles.She reported recent weight gain after hysterectomy and oophorectomy.She claimed having intermittent scaling of elbows, dry eyes and mouth.There was a concern for psoriatic arthritis vs reactive arthritis.She started sulfasalazine and she developed constipation/sob (shortness of breath).She noted puffiness/edema with ssz (sulfasalazine).Per notes, arava caused sob.After her mesh removal on (b)(6) 2019, the patient continues to have joint pain and swelling, but this has improved.Her morning stiffness lasts for less than ten minutes.She has had two episodes of eye inflammation, and this was treated with topical therapy.Furthermore, the patient complained of bilateral hand, hips, lower back, knee and right foot pain/swelling.She stated that her pain has improved but believes she would tolerate the injections better.History of present illness: fatigue and joint pain.Pain: yes level of pain: 4.Since last visit: better.Morning stiffness: 30 min.Onset: (b)(6) 2017.Location: foot -left, foot - right, elbow -left, elbow - right, shoulder -left, shoulder - right quality: aching, stabbing.Severity: 4-6 moderate.Duration: months -11/2017.Timing; upon exertion.Context: activity.Mod.Factors: cortizone shot, steroids, meloxicam, tramadol symptoms: back pain, stiffness of joints, decreased activity 1 adl function has tried: cortizone shot, steroids, mejoxicam-12/2018- 3 days, then reaction, arava- 12/2018- 3 days, then reaction- sob, tramadol- 1/28/19- current (as needed), ssz constipation, sob, mtx (had episode of swelling and stopped).Review of systems: gastrointestinal: nausea.Genitourinary: negative.Diagnoses: pain in unspecified joint elevated erythrocyte sedimentation rate.Pain in joints of left and right hands.Unspecified scleritis unspecified eye.Inflammatory polyarthropathy.Arthropathic psoriasis, unspecified vs reactive arthritis.Care plan: laboratories: drug monitoring.Medications: switch to mtx 25mg/ml.6ml subcutaneous weekly, disp 4ml refill 2.Pt will try dextromethorphan (she reported h/o elevated heart rate but also had similar issues with ocps).She has taken dextromethorphan in cold formulas without issues.Consider ssz.Follow up: 3 months.

Manufacturer Narrative

Blocks a4, b5, b7, h6: patient and impact codes have been updated based on the new information received on september 22, 2022.Block b3: date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6) hospital by dr.(b)(6).Block h6: the following patient codes capture the reportable events below: e2330 - bladder/back pain e1310 - urinary tract infection e0127 - paresthesia e1002 - abdominal pain e2114 - urethral tear e2015 - reactive arthritis e0402 - allergic reaction to the sling e2101 - adhesions e2313 - fibrosis e2007 - multiple falls e1301 - dysuria e1906 - infection e2101 - adhesions e1705 - burning sensation e1302 - hematuria e1309 - urinary retention e2328 - urethral obstruction e1715 - scar tissue e1405 - dyspareunia the following impact codes capture the reportable events below: f1903 - mesh removal f2303 - medication required.F1202 - limited activity due to pain f1901 - urethrolysis.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system was implanted on (b)(6) 2017.As reported by the patient's attorney, the patient experienced an unknown injury.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.***additional information received on 19jan2022*** it was reported that the patient had been diagnosed with stress urinary incontinence with an element of uterine prolapse.On (b)(6) 2017, she underwent a lynx mid-urethral sling placement procedure with cystoscopy and vaginal hysterectomy.Patient tolerated the procedure well with no complications.Patient went for a follow-up visit on (b)(6) 2017 stating she had been doing well and voiding without difficulty.She denies any stress incontinence but is having a small amount of post voiding dribbling after she stands up after urinating.A month later she reported during her 6-week follow-up on (b)(6) 2017 that all of her symptoms have resolved, and she is dry.On (b)(6) 2017, patient reports stating she felt a significant twinge and bladder spasm as she was lifting a box of candied apples three days ago.She had to go to the emergency room due to the incident.She was treated with rocephin and placed on cipro for possible urinary tract infection.No culture was sent, and a dip urine was not available for review.She was still continent and emptying well.On (b)(6) 2019, patient presented for possible mesh infection.She was diagnosed with reactive arthritis and reporting that she has been having problems since after the mesh placement that she thinks is related to her mesh and wanted to undergo mesh removal to hopefully resolve her symptoms.However, multiple ct scans of the abdomen had been performed and did not show any problems on the mesh, no fistula or drainage.Urine cultures in the past did not grow anything except some regular flora.A different physician submitted urine pcr which showed enterococcus faecalis and acinetobacter sensitive to quinolones.She was placed on macrodantin chronically for over a month and was told she was to take it for over a year but was scared of that.She wanted to remain on antibiotics until after the mesh removal procedure.The impression was cystitis.She was prescribed cipro 250 twice a day for two weeks until she has the surgery as well as amoxicillin 875 p.O.B.I.D.For 2 weeks and due to risk of vaginal yeast infection was given diflucan 100 mg p.O.Daily for 2 weeks.Patient was to stop macrodantin.C reactive protein (crp), complete blood count (cbc), and comprehensive metabolic panel were performed.On (b)(6) 2019, patient underwent mesh removal procedure.At the follow-up on (b)(6) 2019, the patient was noted to be doing fine post-removal of the mesh with the wound healing up okay.On (b)(6) 2019, patient presented to a neurology clinic for evaluation of paresthesias in the right leg.She reported that following hysterectomy and mesh placement, she had a complication and infection that required extensive antibiotics.Post mesh placement she has noted pain in the right lower quadrant of the abdomen.Pain appears on straining and continues to happen on and off.She also has noted numbness in her right leg.The numbness is severe in intensity with almost no sensations in the leg.For the last few months, the numbness had appeared about once a week and lasted for half an hour or so; she had fewer episodes of numbness prior to this.Patient has been seeing a rheumatologist for diagnosis of reactive arthritis and undergoing treatments for the same.Additionally, patient has mild and low chronic back pain with radiation on the right side.In the review of systems, the patient indicated she had dysuria, urinary incontinence, rash, back pain, joint pain, muscle weakness, pain radiating down arms/legs, and bruising.The assessment included numbness of the right lower extremity with the exam significant for mild pain in the right calf, right-sided arthritis, and lateral deviation of the right leg; differential diagnoses included lumbar spine pathology or pelvic pathology (e.G.Abscess).The plan was for lumbar spine mri, which if normal, would be followed by pelvis mri.The assessment also included right-sided low back pain with right-sided sciatica, other chronic pain, and bmi of 33.0-33.9.***additional information received on july 18, 2022*** the patient was noted to have developed reaction to the pubovaginal sling with multiple somatic complaints.With removal of the sling in january 2019, she developed relatively severe stress incontinence related to sphincter deficiency.The patient was admitted to the hospital on (b)(6) 2019 following harvest of the rectus fascia sheath and pubovaginal sling procedure.During the vaginal portion of the procedure, dense adhesions and fibrosis were noted over the urethra, as expected.The patient had urethral tear as well during the dissection from urethra to endopelvic fascia.Prolene sutures were secured in the suprapubic wounds coapting the sling to the urethra.A vaginal pack was also placed into the wound.After the procedure, the patient was taken from the operating room to the recovery room in stable condition.On (b)(6) 2021, the patient was diagnosed with lumbosacral spondylosis with radiculopathy and chronic pain syndrome.She reported that post implant, she developed the following: right groin pain; reactive arthritis which has caused flares of inflammation all over her body; low back pain with radiating pain down her right leg; and numbness when she goes to sleep.She reported she had about three episodes of not being able to move her right leg and had multiple falls.History of present illness: initial evaluation: (b)(6) 2021.Date of onset: (b)(6) 2021.Concurrent: no concurrent services medical care prior to current episode: mri: spondylotic changes l4-l5 with spinal stenosis, l4-5 disc degeneration with annulus tear and diffuse bulging with central protrusion, injections.History of present illness: chronic back pain with recent worsening of symptoms illness severity or complexity: chronic pain, mri results.Body part/system being evaluated: lumbar.Reported current functional limitations: 1.Activity intolerance - difficulty prolonged standing, walking.2.Falls - difficulty going up her stairs at home.3.Disturbed sleep every night.Pain assessment: constant low back radiating down to bilateral posterior hips; sometimes radiating down posterior leg to knee.Worse when standing, walking, bending over.Better: "nothing" hot pad, aleve every day.Current: 6/10 average: 6/10 worst: 10/10.Premorbid functional status: chronic back pain x4 years.Work/education/play: limited activity due to her pain.Palpation: tender throughout lumbar spine and hips.Modified oswestry low back pain disability questionnaire: pain intensity: the pain is moderate and does not vary much personal care: washing and dressing increases her pain, and she finds it necessary to change the way she does it.Lifting: she can lift only very light weights.Walking: pain prevents the patient from walking intermediate distances.Sitting: pain prevents her from sitting for more than 1 hour.Standing: she can stand but her pain increases with time.Sleeping: her sleep is only half of her normal amount due to pain.Social life: pain prevents her from going out very often.Traveling: she gets increased pain when traveling, but it does not cause her to seek alternative forms of travel.Employment/homemaking: she can perform most of her job/homemaking duties, but pain prevents her from performing more physically stressful activities (ex.Lifting, vacuuming, etc.).Treatment: no treatment.Assessment/plan: patient education: education provided to patient: home program, plan of care mode of patient education: explanation, demonstration, printed material patient education response: verbal understanding, needs practice/reinforcement weaknesses : chronic and worsening pain.Flags present : yellow flags present: depression.Summary of evaluation: patient presented to physical therapist with diagnosis of lumbosacral spondylosis with radiculopathy.She reported a history of chronic back pain that has worsened and multiple falls.She demonstrated decreased lumbar and left hip rom/flexibility, decreased core stability and decreased right hip strength.She will benefit from pt to address these areas in order to reduce her pain and improve her function/reduce fall risk.Assessment : rehabilitation potential: patient's condition has potential to improve patient's motivation/commitment to rehab/treatment: good.Patient's support structure: family/caregiver was willing and able to support patient and participate in his/her.Rehabilitation plan of care.Recommended consults: none at this time.Patient requires a skilled therapy plan: return to premorbid environment.To reduce need for assist with functional activity/adls/mobility.To return to work.To function in community.**additional information received on september 22, 2022: on (b)(6) 2017, the patient complained of pain in pelvis, bladder pain and bladder spasms that began a day ago.She reportedly recovered well after her sling procedure in 2017 until a day ago, she started to experience frequent bladder spasms that were coming every 20 seconds and now she had difficulty passing urine.She rated pain as 7 out of 10, 8 out of 10 when at worst and level that was acceptable was 0 out of 10.She described her pain as burning and sharp.Current medications: antispasmodic.Bladder scan showed 18 ml, and quick catheter was inserted to obtain a urine specimen that was orange-tinged.The patient was administered toradol and rocephin and was discharged home with plans to follow up with her provider.Assessment: pain gastrointestinal: the patient reported normal bowel habits.Genitourinary: she reported urinary frequency for 1 day and bladder spasms.On (b)(6) 2018, she reported that she suspected she has some urgency and frequency, but she admitted drinking a lot of fluids during the day and before bedtime.On exam, the patient's suprapubic incisions appeared healed without fluctuance or erythema.All vaginal incisions were intact and there was no leakage with valsalva.There was no evidence of sling extrusion, tenderness, periurethral banding or over correction of the urethral angle.There was some aymptomatic rectocele remaining.Furthermore, her urine test showed small blood.Impression: 1.Patient was pleased as her mixed incontinence resolved after sling surgery.2.Urgency, frequency and nocturia due to high fluid intake.3.Multiple somatic symptoms (weight gain, muscle and joint pain, red eyes, elbow and wrist tendonitis and whole body discomfort) developing acutely approximately 4-5 months ago following a sinus infection and major reaction to medication.Patient was undergoing multiple workups with multiple specialists.Plan: 1.She was to continue her follow-up with her physicians.On (b)(6) 2019, the patient presented for moderate urinary tract infection.Associated symptoms included incomplete bladder emptying, slow stream, urinary urgency, lower abdominal pain and vaginal pain.It was noted during the visit that her pain was improving.Review of systems and physical exam noted normal.Assessment/plan: 1.Acute lower uti.Urinalysis performed during the visit.2.Urge incontinence.The patient was scheduled for sling removal, likely vaginal and abdominal approach.On (b)(6) 2019, the patient presented for excision of pubovaginal sling with urethrolysis.Her pre and postoperative diagnoses included pelvic pain and urethral obstruction.During admission for the procedure, she also reported severe dyspareunia, frequency, urgency, and weak stream.Findings: sling appeared to be in good position with no evidence of infection.There was dense scar tissue around the urethra.The sling was cut in the midline at the level of the urethra, dissected laterally on each side and remained intact through the endopelvic fascia and up to the abdominal wall.An abdominal approach was then used to dissect each arm of the sling to the rectus fascia, and the sling was excised completely.After the procedure, the patient was taken to the recovery room in stable condition.On (b)(6) 2019, the patient complained of urinary incontinence.After her mesh removal in january 2019, she developed severe stress incontinence related to sphincter deficiency.The patient was then admitted to the hospital following harvest of the rectus fascia sheath and pubovaginal sling.Assessment: stress incontinence.Intrinsic sphincter deficiency.***additional information received on october 24, 2022*** on (b)(6) 2018, the patient presented for flexible cystoscopy, which showed normal results.There was no evidence of sling erosion or pelvic organ prolapse.With manipulation and probing, she had moderate tenderness of the mid-urethra as well as reported severe tenderness of the entire posterior vaginal wall.The patient was insistent that the systems were related to the mesh.It was explained that there was no indication of improper or abnormal placement or migration of her sling, and there was no evidence of erosion or extrusion.The patient reported that approximately six months after her mesh implant in (b)(6) 2017, she has had a myriad of new complaints including abdominal pain.Swelling, bloating.Pelvic pain, utis, scleritis.Joint pain and others.Her test showed negative for uti.Preoperative and postoperative diagnoses were noted as pelvic pain and self-reported utis.On (b)(6) 2020, the patient presented for evaluation of arthralgias in elbows, shoulders, hands and ankles.She reported recent weight gain after hysterectomy and oophorectomy.She claimed having intermittent scaling of elbows, dry eyes and mouth.There was a concern for psoriatic arthritis vs reactive arthritis.She started sulfasalazine and she developed constipation/sob (shortness of breath).She noted puffiness/edema with ssz (sulfasalazine).Per notes, arava caused sob.After her mesh removal on (b)(6) 2019, the patient continues to have joint pain and swelling, but this has improved.Her morning stiffness lasts for less than ten minutes.She has had two episodes of eye inflammation, and this was treated with topical therapy.Furthermore, the patient complained of bilateral hand, hips, lower back, knee and right foot pain/swelling.She stated that her pain has improved but believes she would tolerate the injections better.History of present illness: fatigue and joint pain.Pain: yes level of pain: 4.Since last visit: better.Morning stiffness: 30 min.Onset:(b)(6) 2017.Location: foot -left, foot - right, elbow -left, elbow - right, shoulder -left, shoulder - right.Quality: aching, stabbing.Severity: 4-6 moderate.Duration: (b)(6) 2017.Timing; upon exertion.Context: activity.Mod.Factors: cortizone shot, steroids, meloxicam, tramadol symptoms: back pain, stiffness of joints, decreased activity 1 adl function has tried: cortizone shot, steroids, mejoxicam-12/2018- 3 days, then reaction, arava- (b)(6) 2018- 3 days, then reaction- sob, tramadol- 1/28/19- current (as needed), ssz constipation, sob, mtx (had episode of swelling and stopped) review of systems: gastrointestinal: nausea.Genitourinary: negative.Diagnoses: pain in unspecified joint.Elevated erythrocyte sedimentation rate.Pain in joints of left and right hands.Unspecified scleritis unspecified eye.Inflammatory polyarthropathy.Arthropathic psoriasis, unspecified vs reactive arthritis.Care plan: laboratories: drug monitoring medications: switch to mtx 25mg/ml.6ml subcutaneous weekly, disp 4ml refill 2.Pt will try dextromethorphan (she reported h/o elevated heart rate but also had similar issues with ocps).She has taken dextromethorphan in cold formulas without issues.Consider ssz.Follow up: 3 months.***additional information received on august 25, 2023*** on (b)(6) 2018, the patient presented for a follow-up checkup.She reported experiencing pain and swelling in both hands and right foot, along with muscle cramps (also known as charley horses).The patient also mentioned being hospitalized for abdominal pain in october 2018.History of present illness.Fatigue, joint and muscle pain, numbness, forgetfulness.Pain: yes level of pain: 6.Since the last visit: same.Morning stiffness: several hours.Onset: (b)(6) /2017.Location: foot - left, foot - right, elbow - left, elbow - right, shoulder - left, shoulder - right.Quality: aching, stabbing.Severity: 4-6 moderate.Duration: (b)(6) 2017.Timing: upon exertion.Context: activity.Mod.Factors: cortisone shot, steroids, meloxicam.Symptoms: joint pain, swelling.Has tried: cortisone shot, steroids, meloxicam.Review of systems: constitutional: fatigue.Eyes: blurred vision, dry eye.Gastrointestinal: abdominal pain, constipation.Genitourinary: hematuria.Musculoskeletal: joint pain, back pain, joint stiffness, joint swelling.Skin: yeast infection under the breast.Neurological: dizziness, muscular weakness.Diagnosis: pain in the unspecified joint.Unspecified vitamin d deficiency.Elevated erythrocyte sedimentation rate.Low back pain.Pain in joints of left and right hands.Pain in the left and right ankle.Unspecified scleritis unspecified eye.Inflammatory polyarthropathy.During a wellness examination on (b)(6) 2019, the patient was found to be experiencing fatigue and urinary incontinence upon review of her symptoms.On (b)(6) 2021, the patient visited the clinic with chief complaints: left upper extremity pain - the patient describes the pain as an ache deep, numbness, and shooting.Symptoms are relieved by ice and distraction techniques.Low back and leg pain - the pain is radiated to the left groin and the lower left extremity (lle).The patient describes the pain as an ache, deep, numbness, and shooting.Symptoms are aggravated by movement.Symptoms are relieved by ice and distraction techniques.Her pain scale is at 8/10.Physical exam: back/spine: the spine is positive for posterior tenderness.Paravertebral muscle spasm.Right, lumbar tenderness was noted.Straight leg test: right positive for back and leg pain at 30 degrees.Assessment: lumbosacral spondylosis with radiculopathy.Impression: the patient presents with right lumbar radiculopathy in the l3-4 distribution as her primary pain complaint today.She has a secondary pain complaint of right upper extremity cervical radiculopathy.She has not tried physical therapy or chiropractic therapy.She has also been recently diagnosed with psoriatic arthritis.X-rays of the cervical and lumbar spine show degenerative disc disease at both locations.Patient plan: lumbar mri without contrast.Consider injections depending on the result.She has right lumbar radiculopathy.No opioids are given per patient request.Continue tylenol and ibuprofen as needed.

Manufacturer Narrative

Blocks h2: additional information blocks b5 (event description) and h6 (patient codes) has been updated based on the additional information received on july 25, 2023.Correction: block e1 (initial reporter title and zip code) has been updated.Block b3: date of event: date of event was approximated to (b)(6) 2017 (first clinic visit post implant) as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6) the following patient codes capture the reportable events below: e2330 - bladder/back pain.E1310 - urinary tract infection.E0127 - paresthesia.E1002 - abdominal pain.E2114 - urethral tear.E2015 - reactive arthritis.E0402 - allergic reaction to the sling.E2101 - adhesions.E2313 - fibrosis.E2007 - multiple falls.E1301 - dysuria.E1906 - infection.E2101 - adhesions.E1705 - burning sensation.E1302 - hematuria.E1309 - urinary retention.E2328 - urethral obstruction.E1715 - scar tissue.E1405 - dyspareunia.E1635 - stiffness of joints.E2312 - fatigue.E2338 - swelling.E020202 - depression.E0127 - numbness.E2401 - right lumbar radiculopathy.The following impact codes capture the reportable events below: f1903 - mesh removal.F2303 - medication required.F1202 - limited activity due to pain.F1901 - urethrolysis.F2203 - imaging required.

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Brand Name

LYNX SYSTEM

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

FREUDENBERG MEDICAL MIS INC

2301 centennial boulevard

jeffersonville IN 47130

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

9309019

MDR Text Key

166055099

Report Number

3005099803-2019-05339

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718949

UDI-Public

08714729718949

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K020110

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

11/12/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

10/19/2019

Device Model Number

M0068503000

Device Catalogue Number

850-300

Device Lot Number

0000046152

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

07/25/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

10/19/2016

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Disability; Required Intervention; Other;

Patient Age

38 YR

Patient Sex

Female

Patient Weight

82 KG

Patient Ethnicity

Non Hispanic

Patient Race

White

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

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