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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Back to Search Results |
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| Model Number M0068503000 |
| Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Erosion (1750); Dyspnea (1816); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Burning Sensation (2146); Dizziness (2194); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Obstruction/Occlusion (2422); Unspecified Blood or Lymphatic problem (4434); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 08/01/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of mesh removal surgery.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 representation.The implant surgeon is: (b)(6).(b)(4).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.
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Event Description
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It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2012.After the procedure, the patient experienced an unknown injury and had the mesh removed on (b)(6) 2019.
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Manufacturer Narrative
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Additional information: blocks b3, b5, d6b, e1: initial reporter and e1 below, h6: patient codes and impact codes.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6), 2018 was chosen as a best estimate when the patient was admitted in (b)(6) 2018 due to symptoms.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2006, e2330, e1309, e2328, e1310, e0306, e2015, e0127 and e0123 capture the reportable events of extrusion; hesitancy and incomplete emptying; ct scan showed patient passed a stone; recurrent/frequent utis; urosepsis; vaginal atrophy; pain; decreased sensation of the left anterior thigh and pelvic nerve issue.Impact code f1202, f08, f1905 and f2303 capture the reportable events of trouble with activities of daily living secondary to the pain; patient was admitted for urosepsis; removal of exposed mesh and medications taken.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.
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Event Description
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It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic tension-free vaginal tape with the lynx kit procedure performed on (b)(6), 2012 for the treatment of stress urinary incontinence.In (b)(6) 2018,the patient was admitted for urosepsis.Two blood cultures were positive for e.Coli.Ct scan also showed she passed a stone at the time.On (b)(6), 2019, the patient was seen on referral for evaluation of recurrent urinary tract infections (uti).The patient had been on antibiotics four times so far that year.It was noted that a urine culture was positive for e.Coli on (b)(6), 2019; on (b)(6), 2019 a urine culture grew mixed flora; on (b)(6), 2019 the patient was seen at urgent care for a uti and was prescribed cefuroxime and pyridium; and on (b)(6), 2019 a urine culture was negative.On (b)(6), 2019, the patient's hba1c was 9.2 which she noted was fairly usual for her now being off her insulin pump for a while due to a severe reaction from the adhesive.During the review of systems, the patient reported urgency, frequency, nocturia, hesitancy, urinary leakage, and the sensation of incomplete emptying.Exam revealed that the mesh sling was completely eroded and outside the vaginal mucosa.Vaginal atrophy was also noted in patient.The assessment was recurrent uti and erosion of the suburethral sling.Referral to urogynecology for recurrent uti and removal of exposed mesh was discussed as the exposed mesh may be nidus of infection.Plan for mesh removal was in (b)(6) 2019.On (b)(6), 2019, the patient had a preoperative exam.Cystoscopy was performed and noted to be normal.Urinalysis showed trace leukocytes in urine, but patient was symptomatic, so macrobid was started for prevention given her history of utis and the cystoscopy performed.Urine culture was submitted.On (b)(6), 2019, the patient underwent removal of exposed midurethral sling and cystourethroscopy for the preoperative diagnoses of extrusion through periurethral vaginal mucosa with sling exposed in vagina, recurrent utis, and poorly controlled diabetic.Findings included eroded sling mesh about 1-2cm on left periurethral sulcus and 1-2 in the right periurethral sulcus.There was a band of 1cm mucosa covering the sling in the midline.During the procedure, the left exposed mesh was grasped and dissected laterally and towards the midline and cut out.This was repeated on the right side.No other mesh was palpated or exposed.Patient tolerated the surgery well, was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6), 2021, the patient visited the spine clinic.She reported pain in her bilateral anterior groin area that started 6 years prior (2015) and reported that recently over the past several months she had some occasional pain in the left anterior thigh.She had been treated with extensive nonoperative care and had physical therapy and injections.She originally was treated in 2014 but the injections had not given her long-term relief.She had seen several spine surgeons, underwent l4-5 laminectomy in 2020, however, this did not alleviate her groin pain.She had seen orthopedic surgeons that concentrated on the hip and they reassured that this is not a hip issue.It was determined that the sling was the source of the infections, but it was cleared up after the mesh was removed.She was starting to have trouble with activities of daily living secondary to the pain.She stated she could only walk for about 10 minutes before she had to stop because of the pain.Sitting made the pain better.Standing also exacerbates the pain.She had to take chronic pain medications for the symptoms.On exam, there was slightly decreased sensation of the left anterior thigh.Ap lateral and lateral flexion-extension x-rays of her lumbar spine were reviewed from (b)(6), 2021 which showed degenerative disc disease with some degenerative scoliosis and marked disc space collapse at l2-3, l3-4 and l4-5.Mrl of her lumbar spine from (b)(6), 2021 revealed lumbar degenerative disc disease with foraminal stenosis at l2-3 and l3-4; mild foraminal stenosis at l4-5 with a large laminectomy defect at la-5.Ls-s1 was fairly well preserved without obvious foraminal stenosis or nerve root impingement of the exiting l5 nerve root.Impression: 1.Possible lumbar symptomatic stenosis 2.Lumbar degenerative disc disease 3.Degenerative scoliosis.The patient was advised that it could not be determined if her symptoms were coming from her spine as there is no nerve compression at the foramen at l5-s1.She may have symptomatology from her foraminal stenosis at l2-3 and l3-4, and an l3-4 and l4-5 bilateral transforaminal epidural steroid injection was recommended to see if that alleviates the groin pain.If the spine injection does nothing for her groin pain, then there may be some sort of pelvic nerve issue and she may want to see someone for a nerve stimulator if the injections do not affect her groin pain.
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Event Description
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It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic tension-free vaginal tape with the lynx kit procedure performed on (b)(6) 2012 for the treatment of stress urinary incontinence.In (b)(6) 2018,the patient was admitted for urosepsis.Two blood cultures were positive for e.Coli.Ct scan also showed she passed a stone at the time.On (b)(6) 2019, the patient was seen on referral for evaluation of recurrent urinary tract infections (uti).The patient had been on antibiotics four times so far that year.It was noted that a urine culture was positive for e.Coli on (b)(6) 2019; on (b)(6) 2019 a urine culture grew mixed flora; on (b)(6) 2019 the patient was seen at urgent care for a uti and was prescribed cefuroxime and pyridium; and on (b)(6) 2019 a urine culture was negative.On (b)(6) 2019, the patient's hba1c was 9.2 which she noted was fairly usual for her now being off her insulin pump for a while due to a severe reaction from the adhesive.During the review of systems, the patient reported urgency, frequency, nocturia, hesitancy, urinary leakage, and the sensation of incomplete emptying.Exam revealed that the mesh sling was completely eroded and outside the vaginal mucosa.Vaginal atrophy was also noted in patient.The assessment was recurrent uti and erosion of the suburethral sling.Referral to urogynecology for recurrent uti and removal of exposed mesh was discussed as the exposed mesh may be nidus of infection.Plan for mesh removal was in (b)(6) 2019.On (b)(6) 2019, the patient had a preoperative exam.Cystoscopy was performed and noted to be normal.Urinalysis showed trace leukocytes in urine, but patient was symptomatic, so macrobid was started for prevention given her history of utis and the cystoscopy performed.Urine culture was submitted.On (b)(6) 2019, the patient underwent removal of exposed midurethral sling and cystourethroscopy for the preoperative diagnoses of extrusion through periurethral vaginal mucosa with sling exposed in vagina, recurrent utis, and poorly controlled diabetic.Findings included eroded sling mesh about 1-2cm on left periurethral sulcus and 1-2 in the right periurethral sulcus.There was a band of 1cm mucosa covering the sling in the midline.During the procedure, the left exposed mesh was grasped and dissected laterally and towards the midline and cut out.This was repeated on the right side.No other mesh was palpated or exposed.Patient tolerated the surgery well, was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6) 2021, the patient visited the spine clinic.She reported pain in her bilateral anterior groin area that started 6 years prior (2015) and reported that recently over the past several months she had some occasional pain in the left anterior thigh.She had been treated with extensive nonoperative care and had physical therapy and injections.She originally was treated in 2014 but the injections had not given her long-term relief.She had seen several spine surgeons, underwent l4-5 laminectomy in 2020, however, this did not alleviate her groin pain.She had seen orthopedic surgeons that concentrated on the hip and they reassured that this is not a hip issue.It was determined that the sling was the source of the infections, but it was cleared up after the mesh was removed.She was starting to have trouble with activities of daily living secondary to the pain.She stated she could only walk for about 10 minutes before she had to stop because of the pain.Sitting made the pain better.Standing also exacerbates the pain.She had to take chronic pain medications for the symptoms.On exam, there was slightly decreased sensation of the left anterior thigh.Ap lateral and lateral flexion-extension x-rays of her lumbar spine were reviewed from (b)(6) 2021 which showed degenerative disc disease with some degenerative scoliosis and marked disc space collapse at l2-3, l3-4 and l4-5.Mrl of her lumbar spine from (b)(6) 2021 revealed lumbar degenerative disc disease with foraminal stenosis at l2-3 and l3-4; mild foraminal stenosis at l4-5 with a large laminectomy defect at la-5.Ls-s1 was fairly well preserved without obvious foraminal stenosis or nerve root impingement of the exiting l5 nerve root.Impression: 1.Possible lumbar symptomatic stenosis.2.Lumbar degenerative disc disease.3.Degenerative scoliosis.The patient was advised that it could not be determined if her symptoms were coming from her spine as there is no nerve compression at the foramen at l5-s1.She may have symptomatology from her foraminal stenosis at l2-3 and l3-4, and an l3-4 and l4-5 bilateral transforaminal epidural steroid injection was recommended to see if that alleviates the groin pain.If the spine injection does nothing for her groin pain, then there may be some sort of pelvic nerve issue and she may want to see someone for a nerve stimulator if the injections do not affect her groin pain.Additional information received on june 3, 2022: on (b)(6) 2021, the patient had l3-4 and l4-5 transforaminal epidural steroid injections which did not give any relief for three days.On (b)(6) 2021, she returned to clinic with her husband.Her back pain and bilateral groin pain have not improved and are essentially unchanged.On physical exam, she was in a walking boot on the left side as she fractured her left foot on (b)(6) 2021 and had 1/5 metatarsal fracture.She had 5/5 motor strength in all motor groups right lower extremity and 5/5 knee flexion and extension.Impression noted at that time includes: 1.Lumbar degenerative disc disease and scoliosis l2-l5.2.Foraminal stenosis l2-3 and l3-4.Plan: the patient's symptoms did not improve or change at all with her injections.The physician was worried that her lumbar spine was not the source of her pain and that her pelvic nerves were injured with the infected mesh.She may have some chronic nerve damage since this has been going on since 2014.The physician does not think a long lumbar scoliosis fusion would alleviate all of her symptoms.The patient might be a candidate for a nerve stimulator.She was then referred to a different doctor for evaluation.
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Manufacturer Narrative
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Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate when the patient was admitted (b)(6) 2018 due to symptoms.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Mesh excision surgeon is: (b)(6).Block h6: patient code e2006, e2330, e1309, e2328, e1310, e0306, e2015, e0127 and e0123 capture the reportable events of extrusion; hesitancy and incomplete emptying; ct scan showed patient passed a stone; recurrent/frequent utis; urosepsis; vaginal atrophy; pain; decreased sensation of the left anterior thigh and pelvic nerve issue.Impact code f1202, f08, f1905 and f2303 capture the reportable events of trouble with activities of daily living secondary to the pain; patient was admitted for urosepsis; removal of exposed mesh and medications taken.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.
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Manufacturer Narrative
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Additional information: blocks b5, b6, b7, h6: patient codes, impact codes, and device codes block b3 date of event: the exact event onset date is unknown.The provided event date of august 01, 2018 was chosen as a best estimate when the patient was admitted in august 2018 due to symptoms.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown., b6, block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.Karlotta m.Davis uchealth at university of colorado amc east phase 2 13001 e.17th place aurora co 80045 mesh excision surgeon is: (b)(6).Block h6: patient code e2006, e2330, e1309, e2328, e1310, e0306, e2015, e012, e0123, e1405, e2015, e2311, e2326 and e1002 capture the reportable events of extrusion; hesitancy and incomplete emptying; ct scan showed patient passed a stone; recurrent/frequent utis; urosepsis; vaginal atrophy; pain; decreased sensation of the left anterior thigh, pelvic nerve issue, no sexual intercourse, distressed (appears uncomfortable), trochanteric bursitis of both hips, tear of acetabular labrum; osteoarthritis of both hips, mild hip arthritis and infection.Impact code f1202, f08, f1905, f2303, f2301 and f1901 capture the reportable events of trouble with activities of daily living secondary to the pain; patient was admitted for urosepsis; removal of exposed mesh and medications taken, bladder sling placed in 2018 and ilioinguinal block.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.
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Event Description
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It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic tension-free vaginal tape with the lynx kit procedure performed on november 5, 2012 for the treatment of stress urinary incontinence.In august 2018,the patient was admitted for urosepsis.Two blood cultures were positive for e.Coli.Ct scan also showed she passed a stone at the time.On (b)(6) 2019, the patient was seen on referral for evaluation of recurrent urinary tract infections (uti).The patient had been on antibiotics four times so far that year.It was noted that a urine culture was positive for e.Coli on (b)(6) 2019; on (b)(6) 2019 a urine culture grew mixed flora; on (b)(6) 2019 the patient was seen at urgent care for a uti and was prescribed cefuroxime and pyridium; and on august 23, 2019 a urine culture was negative.On (b)(6) 2019, the patient's hba1c was 9.2 which she noted was fairly usual for her now being off her insulin pump for a while due to a severe reaction from the adhesive.During the review of systems, the patient reported urgency, frequency, nocturia, hesitancy, urinary leakage, and the sensation of incomplete emptying.Exam revealed that the mesh sling was completely eroded and outside the vaginal mucosa.Vaginal atrophy was also noted in patient.The assessment was recurrent uti and erosion of the suburethral sling.Referral to urogynecology for recurrent uti and removal of exposed mesh was discussed as the exposed mesh may be nidus of infection.Plan for mesh removal was in october 2019.On (b)(6) 2019, the patient had a preoperative exam.Cystoscopy was performed and noted to be normal.Urinalysis showed trace leukocytes in urine, but patient was symptomatic, so macrobid was started for prevention given her history of utis and the cystoscopy performed.Urine culture was submitted.On (b)(6) 2019, the patient underwent removal of exposed midurethral sling and cystourethroscopy for the preoperative diagnoses of extrusion through periurethral vaginal mucosa with sling exposed in vagina, recurrent utis, and poorly controlled diabetic.Findings included eroded sling mesh about 1-2cm on left periurethral sulcus and 1-2 in the right periurethral sulcus.There was a band of 1cm mucosa covering the sling in the midline.During the procedure, the left exposed mesh was grasped and dissected laterally and towards the midline and cut out.This was repeated on the right side.No other mesh was palpated or exposed.Patient tolerated the surgery well, was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6) 2021, the patient visited the spine clinic.She reported pain in her bilateral anterior groin area that started 6 years prior (2015) and reported that recently over the past several months she had some occasional pain in the left anterior thigh.She had been treated with extensive nonoperative care and had physical therapy and injections.She originally was treated in 2014 but the injections had not given her long-term relief.She had seen several spine surgeons, underwent l4-5 laminectomy in 2020, however, this did not alleviate her groin pain.She had seen orthopedic surgeons that concentrated on the hip and they reassured that this is not a hip issue.It was determined that the sling was the source of the infections, but it was cleared up after the mesh was removed.She was starting to have trouble with activities of daily living secondary to the pain.She stated she could only walk for about 10 minutes before she had to stop because of the pain.Sitting made the pain better.Standing also exacerbates the pain.She had to take chronic pain medications for the symptoms.On exam, there was slightly decreased sensation of the left anterior thigh.Ap lateral and lateral flexion-extension x-rays of her lumbar spine were reviewed from march 25, 2021 which showed degenerative disc disease with some degenerative scoliosis and marked disc space collapse at l2-3, l3-4 and l4-5.Mrl of her lumbar spine from april 28, 2021 revealed lumbar degenerative disc disease with foraminal stenosis at l2-3 and l3-4; mild foraminal stenosis at l4-5 with a large laminectomy defect at la-5.Ls-s1 was fairly well preserved without obvious foraminal stenosis or nerve root impingement of the exiting l5 nerve root.Impression: 1.Possible lumbar symptomatic stenosis.2.Lumbar degenerative disc disease.3.Degenerative scoliosis.The patient was advised that it could not be determined if her symptoms were coming from her spine as there is no nerve compression at the foramen at l5-s1.She may have symptomatology from her foraminal stenosis at l2-3 and l3-4, and an l3-4 and l4-5 bilateral transforaminal epidural steroid injection was recommended to see if that alleviates the groin pain.If the spine injection does nothing for her groin pain, then there may be some sort of pelvic nerve issue and she may want to see someone for a nerve stimulator if the injections do not affect her groin pain.*additional information received on june 3, 2022: on september 21, 2021, the patient had l3-4 and l4-5 transforaminal epidural steroid injections which did not give any relief for three days.On (b)(6) 2021, she returned to clinic with her husband.Her back pain and bilateral groin pain have not improved and are essentially unchanged.On physical exam, she was in a walking boot on the left side as she fractured her left foot on september 24, 2021 and had 1/5 metatarsal fracture.She had 5/5 motor strength in all motor groups right lower extremity and 5/5 knee flexion and extension.Impression noted at that time includes: 1.Lumbar degenerative disc disease and scoliosis l2-l5.2.Foraminal stenosis l2-3 and l3-4.Plan: the patient's symptoms did not improve or change at all with her injections.The physician was worried that her lumbar spine was not the source of her pain and that her pelvic nerves were injured with the infected mesh.She may have some chronic nerve damage since this has been going on since 2014.The physician does not think a long lumbar scoliosis fusion would alleviate all of her symptoms.The patient might be a candidate for a nerve stimulator.She was then referred to a different doctor for evaluation.---additional information received on august 8, 16 and 19, 2022--- office visit on (b)(6) 2021: the patient reported she had a bladder sling placed in 2018.She then had a series of infections of her urinary tract and pneumonia.It was finally determined that she had a displacement of the bladder sling and this was removed in 2019.Office visit on (b)(6) 2021: patient's pain began at the end of 2018, beginning of 2019.She cannot associate a specific inciting event, however during that timeframe she did have multiple surgeries including a mesh removal, hysterectomy and a subsequent lumbar laminectomy due to this "hip" pain.Unfortunately the lumbar laminectomy did not help her pain.She reported her pain was in her groin/bilateral lower quadrants of the abdomen.This pain was aggravated or worsened by activity.She had severe pain with standing and walking that is in the left worse than right groin.The pain was also debilitating with rolling over in bed.She did undergo a left ilioinguinal nerve block which did not help her pain with walking but did help her pain when rolling over in bed.Today in clinic she describes the pain is a 6/10 that was a tightening aching both in her low back and her groin.To reduce her pain, she previously tried: physical therapy.L4-5 posterior decompression.Left ilioinguinal nerve block.Additional pain treatments including complementary medications.Other medications for pain office visit on august 25, 2021: assessment: 1.Trochanteric busitis of both hips.2.Tear of acetabular labrum.Chief complaint: hip pain.Associated symptoms include arthralgias, headaches, nausea, numbness, shortness of breath, frequency, back pain, nervous/anxious, sleep disturbance, gait problem, bruises/bleeds easily and urgency.Outside medical records were reviewed noting that she had bilateral hip pain and was referred to physical therapy.Was diagnosed with spondylosis and exam is most consistent with stenosis and started on physical therapy.She was also diagnosed with trochanteric bursitis of both hips and had very short-term relief of her symptoms with recent bursal injections.Recommended physical therapy and anti-inflammatories.Patient was also noted to have tear of acetabular labrum; and primary osteoarthritis of both hips, mild hip arthritis but they seem irritable on exam, no relief with intra-articular injections.It seemed like the pain was not with the hip joint, examination noted the pain was with prolonged standing or walking, thus, this might concern more with lumbar spine in nature.Office visit on (b)(6) 2022: assessment: 1.Abdominal pain, chronic, left lower quadrant the patient had a long history of chronic abdominal pain that has not responded to a diversity of therapeutic trials.She was likely a candidate for neuromodulation.Some areas of tenderness that did not recreate her primary pain problems.Her pelvic pain might not be the primary problem.Patient used a walker, wheelchair, or a cane depending on her pain.Took hydrocodone 6 a day prescribed by an endocrinologist and gabapentin 300 mg 4 times daily.Her primary pain was left side in the groin.This really affects her ability to walk and exercise.No sexual intercourse.On a patient's message, it was stated that another uti started, got high mostly at night and patient would then take pain pill.Urologist did an exam and said the sling back in 2012 was torn and hanging.The area was inflamed and the sling was probably trapping bacteria.Bladder issue had gotten worse since the mesh was removed in october.Constantly wore a poise pad, dripped and wet when cough and sneeze.
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Event Description
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It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic tension-free vaginal tape with the lynx kit procedure performed on (b)(6) 2012 for the treatment of stress urinary incontinence.In august 2018,the patient was admitted for urosepsis.Two blood cultures were positive for e.Coli.Ct scan also showed she passed a stone at the time.On (b)(6) 2019, the patient was seen on referral for evaluation of recurrent urinary tract infections (uti).The patient had been on antibiotics four times so far that year.It was noted that a urine culture was positive for e.Coli on (b)(6) 2019 a urine culture grew mixed flora; on (b)(6) 2019 the patient was seen at urgent care for a uti and was prescribed cefuroxime and pyridium; and on (b)(6) 2019 a urine culture was negative.On (b)(6) 2019, the patient's hba1c was 9.2 which she noted was fairly usual for her now being off her insulin pump for a while due to a severe reaction from the adhesive.During the review of systems, the patient reported urgency, frequency, nocturia, hesitancy, urinary leakage, and the sensation of incomplete emptying.Exam revealed that the mesh sling was completely eroded and outside the vaginal mucosa.Vaginal atrophy was also noted in patient.The assessment was recurrent uti and erosion of the suburethral sling.Referral to urogynecology for recurrent uti and removal of exposed mesh was discussed as the exposed mesh may be nidus of infection.Plan for mesh removal was in october 2019.On (b)(6) 2019, the patient had a preoperative exam.Cystoscopy was performed and noted to be normal.Urinalysis showed trace leukocytes in urine, but patient was symptomatic, so macrobid was started for prevention given her history of utis and the cystoscopy performed.Urine culture was submitted.On (b)(6) 2019, the patient underwent removal of exposed midurethral sling and cystourethroscopy for the preoperative diagnoses of extrusion through periurethral vaginal mucosa with sling exposed in vagina, recurrent utis, and poorly controlled diabetic.Findings included eroded sling mesh about 1-2cm on left periurethral sulcus and 1-2 in the right periurethral sulcus.There was a band of 1cm mucosa covering the sling in the midline.During the procedure, the left exposed mesh was grasped and dissected laterally and towards the midline and cut out.This was repeated on the right side.No other mesh was palpated or exposed.Patient tolerated the surgery well, was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6) 2021, the patient visited the spine clinic.She reported pain in her bilateral anterior groin area that started 6 years prior (2015) and reported that recently over the past several months she had some occasional pain in the left anterior thigh.She had been treated with extensive nonoperative care and had physical therapy and injections.She originally was treated in 2014 but the injections had not given her long-term relief.She had seen several spine surgeons, underwent l4-5 laminectomy in 2020, however, this did not alleviate her groin pain.She had seen orthopedic surgeons that concentrated on the hip and they reassured that this is not a hip issue.It was determined that the sling was the source of the infections, but it was cleared up after the mesh was removed.She was starting to have trouble with activities of daily living secondary to the pain.She stated she could only walk for about 10 minutes before she had to stop because of the pain.Sitting made the pain better.Standing also exacerbates the pain.She had to take chronic pain medications for the symptoms.On exam, there was slightly decreased sensation of the left anterior thigh.Ap lateral and lateral flexion-extension x-rays of her lumbar spine were reviewed from march 25, 2021 which showed degenerative disc disease with some degenerative scoliosis and marked disc space collapse at l2-3, l3-4 and l4-5.Mrl of her lumbar spine from april 28, 2021 revealed lumbar degenerative disc disease with foraminal stenosis at l2-3 and l3-4; mild foraminal stenosis at l4-5 with a large laminectomy defect at la-5.Ls-s1 was fairly well preserved without obvious foraminal stenosis or nerve root impingement of the exiting l5 nerve root.Impression: 1.Possible lumbar symptomatic stenosis.2.Lumbar degenerative disc disease.3.Degenerative scoliosis.The patient was advised that it could not be determined if her symptoms were coming from her spine as there is no nerve compression at the foramen at l5-s1.She may have symptomatology from her foraminal stenosis at l2-3 and l3-4, and an l3-4 and l4-5 bilateral transforaminal epidural steroid injection was recommended to see if that alleviates the groin pain.If the spine injection does nothing for her groin pain, then there may be some sort of pelvic nerve issue and she may want to see someone for a nerve stimulator if the injections do not affect her groin pain.*additional information received on june 3, 2022: on (b)(6) 2021, the patient had l3-4 and l4-5 transforaminal epidural steroid injections which did not give any relief for three days.On (b)(6) 2021, she returned to clinic with her husband.Her back pain and bilateral groin pain have not improved and are essentially unchanged.On physical exam, she was in a walking boot on the left side as she fractured her left foot on september 24, 2021 and had 1/5 metatarsal fracture.She had 5/5 motor strength in all motor groups right lower extremity and 5/5 knee flexion and extension.Impression noted at that time includes: 1.Lumbar degenerative disc disease and scoliosis l2-l5.2.Foraminal stenosis l2-3 and l3-4.Plan: the patient's symptoms did not improve or change at all with her injections.The physician was worried that her lumbar spine was not the source of her pain and that her pelvic nerves were injured with the infected mesh.She may have some chronic nerve damage since this has been going on since 2014.The physician does not think a long lumbar scoliosis fusion would alleviate all of her symptoms.The patient might be a candidate for a nerve stimulator.She was then referred to a different doctor for evaluation.---additional information received on august 8, 16 and 19, 2022 and september 13, 2022--- past medical history: - back pain.- gastroesophageal reflux disease.- muscle spasm.- restless leg syndrome.Past surgical history: - cervical spine surgery.- hysterectomy.- ir biopsy - 12/4/2018 pkr ir imaging.On a patient's message on september 9, 2019, it was stated that another uti started, got high mostly at night and patient would then take pain pill.Urologist did an exam and said the sling back in 2012 was torn and hanging.The area was inflamed, and the sling was probably trapping bacteria.And on february 24, 2020, bladder issue had gotten worse since the mesh was removed in october.Constantly wore a poise pad, dripped and wet when cough and sneeze.Emergency department notes (b)(6), 2019: patient with type i diabetes and history of utls, presented to the ed with elevated blood sugar and concerned that she may be developing a uti, subjective fevers, vomiting and back pain that she could not delineate from her chronic low back pain versus flank pain/pyelonephritis.She denied any dysuria, frequency or hematuria.She had a history of pyelonephritis and was admitted a few weeks prior.She had cystoscopy the day prior and was placed on nitrofurantoin post procedure.Work-up showed leukocytosis at 11.8.Urine showed trace leukocyte esterase, no nitrites, 6-10 squamous cells, 11-15 white cells, no red cells, 1 + bacteria.Urine appears consistent with the last time she was admitted.Curiously urine culture from that admission showed no growth.Patient was treated symptomatically with iv fluids, pain medicine and nausea medicine.The urologist was consulted and did not feel that her urine was indicative of infection necessarily but noted that the patient does have vaginal mesh that she is going to remove in the near future that she thinks this may be contributing to her chronically contaminated and/or infected appearing uas.Plan was to treat with a dose of iv rocephin in the ed and then switch to bactrim for treatment of a possible pyelonephritis and have the patient seen in the clinic tomorrow.Office visit on october 10, 2019: patient presented for kidney infection and cough.Needed to be cleared of kidney infection before steroid injection.Patient stated she had an office visit for pyelonephritis.Patient continued to experience back pain, shoulder pain, fatigue, cough, nausea, fever, vomiting, and urinary frequency.Denied any burning while urinating.She stated that she had pain in her back and hip all the time.She endorsed that due to her severe back and hip pain she was unaware of when she was passing a kidney stone.She stated that she had bladder surgery of removal of exposed mid-urethral sling on friday, (b)(6) 2019.She noted that following surgery she experienced minimal bleeding and burning.She drank about 1 gallon of water of which helped to relieve the burning she experienced after her bladder surgery.Patient noted she experienced vomiting, fever that reached 104 degrees, intermittent fever and chills, frozen shoulder - steroid injection given.Patient continued with pain of her right shoulder, back pain, hip pain, fatigue, as well as cough.Patient had a poc urinalysis which demonstrated large 3+ leukocyte esterase urine, and blood urine small 1+, as well as elevated glucose in her urine at 250.Urine sent for culture.Review of systems showed patient was positive for chills, fatigue, fever, cough, shortness of breath, nausea, vomiting, frequency and back pain.Negative for dysuria.Emergency department notes on november 17, 2019: patient came with a chief complaint of hip pain.Patient with past medical history significant for chronic pain on chronic oral opiates, diabetes with continuous glucose monitors and insulin use, multiple recent surgeries including surgery to the right shoulder, jaw, reversal of ureteral sling, recurrent urinary tract infections who presents with severe right lower quadrant abdominal pain which is been worsening over the last 4 days now associated with nausea and hyperglycemia also noticed a rash to the abdomen approximately 5 days ago.Pain is severe, right lower quadrant mostly anterior abdominal pain, non-migratory, non-radiating, not burning in nature, not associated with changes in urination, normal bowel movements that have been non-bloody, non-melanotic and not constipated.She has been taking her normal pain medication which is oral dilaudid without relief of this pain.She feels that this pain is very different than prior hip pain or back pain.She has no weakness or numbness in her legs.She has no falls or trauma.Her last urinary tract infection was treated with antibiotics which were completed approximately 1 week ago.Patient reports that her primary care physician has concerns regarding infection that they have not been able to identify source for her.She states that when she is in pain her blood sugars rise, shows me her glucose monitor with elevated blood sugars which are beyond the range of detection of her meter.Past medical history: - back pain.- chronic pain disorder (jaw, shoulders, back, hips).- fibroid.- menopause ovarian failure.- ovarian cyst.- peripheral neuropathy.- urinary incontinence.- urinary tract infection (8/12/2019) - 4 in last 6 months.Past surgical surgery: * bladder surgery (retropubic sling).* bladder suspension (2016).* cystocele repair.* hysterectomy (1ovary spared).Physical exam: constitutional - distressed (appears uncomfortable).Abdominal: tenderness rlq ttp (right lower quadrant tender to palpation) at mcburney's point, minimal ttp over rash along r lateral abdomen and r flank) rash (vesicular rash over r posterior and lateral abdomen, minimal rash on anterior abdomen, no significant surrounding erythema, no drainage or open bullae).Labs ordered and reviewed: abnormality notable for the following components: *blood, urine - trace lysed.*glucose - 194.*bacteria, urine - rare.*squamous epithelial, urine - 21-30.Interpretation: no leukocytosis, no anemia, no thrombocytopenia, mild hyperglycemia but otherwise no significant electrolyte abnormalities, normal lfts (liver function tests), normal lactate, urinalysis without evidence of infection, or blood.Imaging ordered and reviewed: nonspecific changes mid to distal colon, potentially normal variation and related to collapsed state, consider mild colitis in the appropriate clinical setting.Clinical impression: 1.Herpes zoster without complication.2.Murmur, cardiac.Patient also reported right hip and back pain with rash.She recently treated for uti and bladder surgery on (b)(6) 2019.Progress notes on march 2, 2020: assessment and plan: 1.Sepsis without acute organ dysfunction, due to unspecified organism (hc code).2.Pyelonephritis.Patient had frequent utls.On (b)(6) 2020, patient was hospitalized for urosepsis/pyelonephritis due to pneumonia vs partially treated uti, treated with rocephin/azithro.Urinalysis negative for leukocyte esterase/nitrite, urine culture diphtheroids.Finished her antibiotics in (b)(6).Patient had increased risk of infections in general due to diabetes.Had history of pelvic sling for incontinence, mesh has since been removed in october 2019.No other known structural or functional genitourinary abnormality though query neurogenic bladder given history of om.Patient may have atypical symptoms due to concurrent orthopedic-related pain and possible neuropathy.Patient reported uti symptoms: strong odor, dark color to urine.Always has chronic pain so pain is not an indicator for her, including pain from back to groin.No dysuria.Currently reports no uti symptoms but feels fatigued all the time.Recommended: - encouraged increased fluid intake.- trial of methenamine urinary antiseptic.- would avoid prophylactic antibiotics to avoid adverse effects and development of antibiotic resistance.- discussed that urine odor and color are not good indicators of uti; however, because pt seems to have atypical symptoms; advised if she notices dark or malodorous urine, increase fluid intake, if these persist then check ua; if >10 wbc then urine culture.- recommend f/u with her urologist to evaluate for structural abnormalities or urinary retention.Hpi: (b)(6) 2018 - colonoscopy.(b)(6) 2018 - admitted with sepsis x 7 days, bacteremia due to e coli, likely due to pyelonephritis? passed kidney stone.(b)(6) 2018 - another uti.(b)(6) 2019 - uti e coli.(b)(6) 2019 - check up - uti.(b)(6) 2019 - shoulder surgery after fall (rotator cuff surgery, no prosthesis), now c/b frozen shoulder.(b)(6) 2019 - admitted for 5 days for pyelonephritis, saw urologist - wanted to remove loose mesh.(b)(6) 2019 - jaw surgery - admitted x 3 days.(b)(6) 2019 - bladder surgery - mesh removed (now incontinent again).(b)(6) - uti.(b)(6) 2020- uti.Outpatient referral for: - chronic utls, history of sepsis.- diphtheroids in urine.Office visit on april 29, 2021: the patient reported she had a bladder sling placed in 2018.She then had a series of infections of her urinary tract and pneumonia.It was finally determined that she had a displacement of the bladder sling, and this was removed in 2019.She returned after having an ilioinguinal injection and a repeat mri.She did not get diagnostic relief of her symptoms after this block.She had this pain since 2019, severe pain with standing and walking that is in the left worse than right groin, and debilitating pain with rolling over in bed.She was feeling confined to her house most days, she was unable to walk more than 1/8th of a block at time.She had a morton's neuroma removed the previous week and was currently using a scooter.The lumbar mri showed a left nf narrowing at l4 and on the right at l3.She did not have pain in these distributions in her legs.She had an emg which showed a mild chronic l5 radiculopathy on the right without active denervation.These findings did not point to the spine as a source of her pain.She saw a hip specialist who determined that her pain was not coming from her hip.She did have an intra-articular hip injection with no relief of her symptoms.Office visit on (b)(6) 2021: patient's pain began at the end of 2018, beginning of 2019.She cannot associate a specific inciting event, however during that timeframe she did have multiple surgeries including a mesh removal, hysterectomy and a subsequent lumbar laminectomy due to this "hip" pain.Unfortunately, the lumbar laminectomy did not help her pain.She reported her pain was in her groin/bilateral lower quadrants of the abdomen.This pain was aggravated or worsened by activity.She had severe pain with standing and walking that is in the left worse than right groin.The pain was also debilitating with rolling over in bed.She did undergo a left ilioinguinal nerve block which did not help her pain with walking but did help her pain when rolling over in bed.Today in clinic she describes the pain is a 6/10 that was a tightening aching both in her low back and her groin.To reduce her pain, she previously tried: - physical therapy.- l4-5 posterior decompression.- left ilioinguinal nerve block on april 8, 2021- this injection did not provide much benefit.- additional pain treatments including complementary medications.- other medications for pain.The assessment included lower abdominal pain, myofascial muscle pain, type 1 diabetes with hypoglycemia, and chronic right-sided low back pain without sciatica.The physician noted that as opposed to a frank hip or low back issue that this may be an abdominal issue, potentially secondary to her previous surgeries.The plan was to perform a left-sided q l 1 injection along with trigger point injections.Office visit on (b)(6) 2021: assessment: 1.Trochanteric bursitis of both hips.2.Tear of acetabular labrum.Chief complaint: hip pain.Associated symptoms include arthralgias, headaches, nausea, numbness, shortness of breath, frequency, back pain, nervous/anxious, sleep disturbance, gait problem, bruises/bleeds easily and urgency.Outside medical records were reviewed noting that she had bilateral hip pain and was referred to physical therapy.Was diagnosed with spondylosis and exam is most consistent with stenosis and started on physical therapy.She was also diagnosed with trochanteric bursitis of both hips and had very short-term relief of her symptoms with recent bursal injections.Recommended physical therapy and anti-inflammatories.Patient was also noted to have tear of acetabular labrum; and primary osteoarthritis of both hips, mild hip arthritis but they seem irritable on exam, no relief with intra-articular injections.It seemed like the pain was not with the hip joint, examination noted the pain was with prolonged standing or walking, thus, this might concern more with lumbar spine in nature.Office visit on (b)(6) 2022: assessment: 1.Abdominal pain, chronic, left lower quadrant.The patient had a long history of chronic abdominal pain that has not responded to a diversity of therapeutic trials.She was likely a candidate for neuromodulation.Some areas of tenderness that did not recreate her primary pain problems.Her pelvic pain might not be the primary problem.Patient used a walker, wheelchair, or a cane depending on her pain.Took hydrocodone 6 a day prescribed by an endocrinologist and gabapentin 300 mg 4 times daily.Her primary pain was left side in the groin.This really affects her ability to walk and exercise.No sexual intercourse.
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Manufacturer Narrative
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Additional information: blocks b5 and h6: patient codes have been updated based on the information received on september 13, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of august 01, 2018 was chosen as a best estimate when the patient was admitted in august 2018 due to symptoms.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Mesh excision surgeon is: dr.(b)(6).Block h6: patient code e2006, e2330, e1309, e2328, e1310, e0306, e2015, e012, e0123, e1405, e2015, e2311, e2326 and e1002 capture the reportable events of extrusion; hesitancy and incomplete emptying; ct scan showed patient passed a stone; recurrent/frequent utis; urosepsis; vaginal atrophy; pain; decreased sensation of the left anterior thigh, pelvic nerve issue, no sexual intercourse, distressed (appears uncomfortable), trochanteric bursitis of both hips, tear of acetabular labrum; osteoarthritis of both hips, mild hip arthritis and infection.Impact code f1202, f08, f1905, f2303, f2301 and f1901 capture the reportable events of trouble with activities of daily living secondary to the pain; patient was admitted for urosepsis; removal of exposed mesh and medications taken, bladder sling placed in 2018 and ilioinguinal block.Block h11: block b5 has been updated with the information not previously reported.
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Manufacturer Narrative
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Additional information: blocks a5, a6, and b5 have been updated based on the additional information received on august 15, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of august 01, 2018, was chosen as a best estimate when the patient was admitted in (b)(6) 2018 due to symptoms.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).Mesh excision surgeon is: dr.(b)(6).(b)(6).Block h6: imdrf patient code e2006, e2330, e1309, e2328, e1310, e0306, e2015, e012, e0123, e1405, e2015, e2311, e2326 and e1002 capture the reportable events of extrusion; hesitancy and incomplete emptying; ct scan showed patient passed a stone; recurrent/frequent utis; urosepsis; vaginal atrophy; pain; decreased sensation of the left anterior thigh, pelvic nerve issue, no sexual intercourse, distressed (appears uncomfortable), trochanteric bursitis of both hips, tear of acetabular labrum; osteoarthritis of both hips, mild hip arthritis and infection.Imdrf impact code f1202, f08, f1905, f2303, f2301 and f1901 capture the reportable events of trouble with activities of daily living secondary to the pain; patient was admitted for urosepsis; removal of exposed mesh and medications taken, bladder sling placed in 2018 and ilioinguinal block.Block 11: blocks e1: initial reporter zip/post code, email, and fax, and g1: mfr site state have been corrected.
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Event Description
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It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a retropubic tension-free vaginal tape with the lynx kit procedure performed on (b)(6) 2012 for the treatment of stress urinary incontinence.In (b)(6) 2018,the patient was admitted for urosepsis.Two blood cultures were positive for e.Coli.Ct scan also showed she passed a stone at the time.On (b)(6) 2019, the patient was seen on referral for evaluation of recurrent urinary tract infections (uti).The patient had been on antibiotics four times so far that year.It was noted that a urine culture was positive for e.Coli on (b)(6) 2019; on (b)(6) 2019 a urine culture grew mixed flora; on (b)(6) 2019 the patient was seen at urgent care for a uti and was prescribed cefuroxime and pyridium; and on (b)(6) 2019 a urine culture was negative.On (b)(6) 2019, the patient's hba1c was 9.2 which she noted was fairly usual for her now being off her insulin pump for a while due to a severe reaction from the adhesive.During the review of systems, the patient reported urgency, frequency, nocturia, hesitancy, urinary leakage, and the sensation of incomplete emptying.Exam revealed that the mesh sling was completely eroded and outside the vaginal mucosa.Vaginal atrophy was also noted in patient.The assessment was recurrent uti and erosion of the suburethral sling.Referral to urogynecology for recurrent uti and removal of exposed mesh was discussed as the exposed mesh may be nidus of infection.Plan for mesh removal was in (b)(6) 2019.On (b)(6) 2019, the patient had a preoperative exam.Cystoscopy was performed and noted to be normal.Urinalysis showed trace leukocytes in urine, but patient was symptomatic, so macrobid was started for prevention given her history of utis and the cystoscopy performed.Urine culture was submitted.On (b)(6) 2019, the patient underwent removal of exposed midurethral sling and cystourethroscopy for the preoperative diagnoses of extrusion through periurethral vaginal mucosa with sling exposed in vagina, recurrent utis, and poorly controlled diabetic.Findings included eroded sling mesh about 1-2cm on left periurethral sulcus and 1-2 in the right periurethral sulcus.There was a band of 1cm mucosa covering the sling in the midline.During the procedure, the left exposed mesh was grasped and dissected laterally and towards the midline and cut out.This was repeated on the right side.No other mesh was palpated or exposed.Patient tolerated the surgery well, was reversed from anesthesia and taken to the recovery room in stable condition.On (b)(6) 2021, the patient visited the spine clinic.She reported pain in her bilateral anterior groin area that started 6 years prior (2015) and reported that recently over the past several months she had some occasional pain in the left anterior thigh.She had been treated with extensive nonoperative care and had physical therapy and injections.She originally was treated in 2014 but the injections had not given her long-term relief.She had seen several spine surgeons, underwent l4-5 laminectomy in 2020, however, this did not alleviate her groin pain.She had seen orthopedic surgeons that concentrated on the hip and they reassured that this is not a hip issue.It was determined that the sling was the source of the infections, but it was cleared up after the mesh was removed.She was starting to have trouble with activities of daily living secondary to the pain.She stated she could only walk for about 10 minutes before she had to stop because of the pain.Sitting made the pain better.Standing also exacerbates the pain.She had to take chronic pain medications for the symptoms.On exam, there was slightly decreased sensation of the left anterior thigh.Ap lateral and lateral flexion-extension x-rays of her lumbar spine were reviewed from (b)(6) 2021 which showed degenerative disc disease with some degenerative scoliosis and marked disc space collapse at l2-3, l3-4 and l4-5.Mrl of her lumbar spine from (b)(6) 2021 revealed lumbar degenerative disc disease with foraminal stenosis at l2-3 and l3-4; mild foraminal stenosis at l4-5 with a large laminectomy defect at la-5.Ls-s1 was fairly well preserved without obvious foraminal stenosis or nerve root impingement of the exiting l5 nerve root.Impression: 1.Possible lumbar symptomatic stenosis.2.Lumbar degenerative disc disease.3.Degenerative scoliosis.The patient was advised that it could not be determined if her symptoms were coming from her spine as there is no nerve compression at the foramen at l5-s1.She may have symptomatology from her foraminal stenosis at l2-3 and l3-4, and an l3-4 and l4-5 bilateral transforaminal epidural steroid injection was recommended to see if that alleviates the groin pain.If the spine injection does nothing for her groin pain, then there may be some sort of pelvic nerve issue and she may want to see someone for a nerve stimulator if the injections do not affect her groin pain.Additional information received on june 3, 2022: on (b)(6) 2021, the patient had l3-4 and l4-5 transforaminal epidural steroid injections which did not give any relief for three days.On (b)(6) 2021, she returned to clinic with her husband.Her back pain and bilateral groin pain have not improved and are essentially unchanged.On physical exam, she was in a walking boot on the left side as she fractured her left foot on (b)(6) 2021 and had 1/5 metatarsal fracture.She had 5/5 motor strength in all motor groups right lower extremity and 5/5 knee flexion and extension.Impression noted at that time includes: 1.Lumbar degenerative disc disease and scoliosis l2-l5.2.Foraminal stenosis l2-3 and l3-4.Plan: the patient's symptoms did not improve or change at all with her injections.The physician was worried that her lumbar spine was not the source of her pain and that her pelvic nerves were injured with the infected mesh.She may have some chronic nerve damage since this has been going on since 2014.The physician does not think a long lumbar scoliosis fusion would alleviate all of her symptoms.The patient might be a candidate for a nerve stimulator.She was then referred to a different doctor for evaluation.Additional information received on august 8, 16 and 19, 2022 and september 13, 2022; past medical history: back pain.Gastroesophageal reflux disease.Muscle spasm.Restless leg syndrome.Past surgical history: cervical spine surgery hysterectomy ir biopsy - (b)(6) 2018 pkr ir imaging.On a patient's message on (b)(6) 2019, it was stated that another uti started, got high mostly at night and patient would then take pain pill.Urologist did an exam and said the sling back in 2012 was torn and hanging.The area was inflamed, and the sling was probably trapping bacteria.And on (b)(6) 2020, bladder issue had gotten worse since the mesh was removed in (b)(6).Constantly wore a poise pad, dripped and wet when cough and sneeze.Emergency department notes (b)(6) 2019: patient with type i diabetes and history of utls, presented to the ed with elevated blood sugar and concerned that she may be developing a uti, subjective fevers, vomiting and back pain that she could not delineate from her chronic low back pain versus flank pain/pyelonephritis.She denied any dysuria, frequency or hematuria.She had a history of pyelonephritis and was admitted a few weeks prior.She had cystoscopy the day prior and was placed on nitrofurantoin post procedure.Work-up showed leukocytosis at 11.8.Urine showed trace leukocyte esterase, no nitrites, 6-10 squamous cells, 11-15 white cells, no red cells, 1 + bacteria.Urine appears consistent with the last time she was admitted.Curiously urine culture from that admission showed no growth.Patient was treated symptomatically with iv fluids, pain medicine and nausea medicine.The urologist was consulted and did not feel that her urine was indicative of infection necessarily but noted that the patient does have vaginal mesh that she is going to remove in the near future that she thinks this may be contributing to her chronically contaminated and/or infected appearing uas.Plan was to treat with a dose of iv rocephin in the ed and then switch to bactrim for treatment of a possible pyelonephritis and have the patient seen in the clinic tomorrow.Office visit on (b)(6) 2019: patient presented for kidney infection and cough.Needed to be cleared of kidney infection before steroid injection.Patient stated she had an office visit for pyelonephritis.Patient continued to experience back pain, shoulder pain, fatigue, cough, nausea, fever, vomiting, and urinary frequency.Denied any burning while urinating.She stated that she had pain in her back and hip all the time.She endorsed that due to her severe back and hip pain she was unaware of when she was passing a kidney stone.She stated that she had bladder surgery of removal of exposed mid-urethral sling on friday, (b)(6) 2019.She noted that following surgery she experienced minimal bleeding and burning.She drank about 1 gallon of water of which helped to relieve the burning she experienced after her bladder surgery.Patient noted she experienced vomiting, fever that reached 104 degrees, intermittent fever and chills, frozen shoulder - steroid injection given.Patient continued with pain of her right shoulder, back pain, hip pain, fatigue, as well as cough.Patient had a poc urinalysis which demonstrated large 3+ leukocyte esterase urine, and blood urine small 1+, as well as elevated glucose in her urine at 250.Urine sent for culture.Review of systems showed patient was positive for chills, fatigue, fever, cough, shortness of breath, nausea, vomiting, frequency and back pain.Negative for dysuria.Emergency department notes on (b)(6) 2019: patient came with a chief complaint of hip pain.Patient with past medical history significant for chronic pain on chronic oral opiates, diabetes with continuous glucose monitors and insulin use, multiple recent surgeries including surgery to the right shoulder, jaw, reversal of ureteral sling, recurrent urinary tract infections who presents with severe right lower quadrant abdominal pain which is been worsening over the last 4 days now associated with nausea and hyperglycemia also noticed a rash to the abdomen approximately 5 days ago.Pain is severe, right lower quadrant mostly anterior abdominal pain, non-migratory, non-radiating, not burning in nature, not associated with changes in urination, normal bowel movements that have been non-bloody, non-melanotic and not constipated.She has been taking her normal pain medication which is oral dilaudid without relief of this pain.She feels that this pain is very different than prior hip pain or back pain.She has no weakness or numbness in her legs.She has no falls or trauma.Her last urinary tract infection was treated with antibiotics which were completed approximately 1 week ago.Patient reports that her primary care physician has concerns regarding infection that they have not been able to identify source for her.She states that when she is in pain her blood sugars rise, shows me her glucose monitor with elevated blood sugars which are beyond the range of detection of her meter.Past medical history: back pain.Chronic pain disorder (jaw, shoulders, back, hips).Fibroid.Menopause ovarian failure.Ovarian cyst.Peripheral neuropathy.Urinary incontinence.Urinary tract infection ((b)(6) 2019) - 4 in last 6 months.Past surgical surgery: bladder surgery (retropubic sling), bladder suspension (2016), cystocele repair, hysterectomy (1ovary spared).Physical exam: constitutional - distressed (appears uncomfortable) abdominal: tenderness rlq ttp (right lower quadrant tender to palpation) at mcburney's point, minimal ttp over rash along r lateral abdomen and r flank) rash (vesicular rash over r posterior and lateral abdomen, minimal rash on anterior abdomen, no significant surrounding erythema, no drainage or open bullae) labs ordered and reviewed: abnormality notable for the following components: blood, urine - trace lysed.Glucose - 194.Bacteria, urine - rare.Quamous epithelial, urine - 21-30.Interpretation: no leukocytosis, no anemia, no thrombocytopenia, mild hyperglycemia but otherwise no significant electrolyte abnormalities, normal lfts (liver function tests), normal lactate, urinalysis without evidence of infection, or blood.Imaging ordered and reviewed: nonspecific changes mid to distal colon, potentially normal variation and related to collapsed state, consider mild colitis in the appropriate clinical setting.Clinical impression: 1.Herpes zoster without complication.2.Murmur, cardiac.Patient also reported right hip and back pain with rash.She recently treated for uti and bladder surgery on (b)(6) 2019.Progress notes on (b)(6) 2020: assessment and plan: 1.Sepsis without acute organ dysfunction, due to unspecified organism (hc code).2.Pyelonephritis.Patient had frequent utls.On (b)(6) 2020, patient was hospitalized for urosepsis/pyelonephritis due to pneumonia vs partially treated uti, treated with rocephin/azithro.Urinalysis negative for leukocyte esterase/nitrite, urine culture diphtheroids.Finished her antibiotics in (b)(6).Patient had increased risk of infections in general due to diabetes.Had history of pelvic sling for incontinence, mesh has since been removed in (b)(6) 2019.No other known structural or functional genitourinary abnormality though query neurogenic bladder given history of om.Patient may have atypical symptoms due to concurrent orthopedic-related pain and possible neuropathy.Patient reported uti symptoms: strong odor, dark color to urine.Always has chronic pain so pain is not an indicator for her, including pain from back to groin.No dysuria.Currently reports no uti symptoms but feels fatigued all the time.Recommended: encouraged increased fluid intake.Trial of methenamine urinary antiseptic.Would avoid prophylactic antibiotics to avoid adverse effects and development of antibiotic resistance.Discussed that urine odor and color are not good indicators of uti; however, because pt seems to have atypical symptoms; advised if she notices dark or malodorous urine, increase fluid intake, if these persist then check ua; if :10 wbc then urine culture.Recommend f/u with her urologist to evaluate for structural abnormalities or urinary retention.Hpi: (b)(6) 2018 - colonoscopy (b)(6) 2018 - admitted with sepsis x 7 days, bacteremia due to e coli, likely due to pyelonephritis? passed kidney stone.(b)(6) 2018 - another uti.(b)(6) 2019 - uti e coli.(b)(6) 2019 - check up - uti.(b)(6) 2019 - shoulder surgery after fall (rotator cuff surgery, no prosthesis), now c/b frozen shoulder.(b)(6) 2019 - admitted for 5 days for pyelonephritis, saw urologist - wanted to remove loose mesh.(b)(6) 2019 - jaw surgery - admitted x 3 days.(b)(6) 2019 - bladder surgery - mesh removed (now incontinent again).End of (b)(6) - uti (b)(6) 3, 2020- uti outpatient referral for: chronic utls, history of sepsis.Diphtheroids in urine.Office visit on (b)(6) 2021: the patient reported she had a bladder sling placed in 2018.She then had a series of infections of her urinary tract and pneumonia.It was finally determined that she had a displacement of the bladder sling, and this was removed in 2019.She returned after having an ilioinguinal injection and a repeat mri.She did not get diagnostic relief of her symptoms after this block.She had this pain since 2019, severe pain with standing and walking that is in the left worse than right groin, and debilitating pain with rolling over in bed.She was feeling confined to her house most days, she was unable to walk more than 1/8th of a block at time.She had a morton's neuroma removed the previous week and was currently using a scooter.The lumbar mri showed a left nf narrowing at l4 and on the right at l3.She did not have pain in these distributions in her legs.She had an emg which showed a mild chronic l5 radiculopathy on the right without active denervation.These findings did not point to the spine as a source of her pain.She saw a hip specialist who determined that her pain was not coming from her hip.She did have an intra-articular hip injection with no relief of her symptoms.Office visit on (b)(6) 2021: patient's pain began at the end of 2018, beginning of 2019.She cannot associate a specific inciting event, however during that timeframe she did have multiple surgeries including a mesh removal, hysterectomy and a subsequent lumbar laminectomy due to this "hip" pain.Unfortunately, the lumbar laminectomy did not help her pain.She reported her pain was in her groin/bilateral lower quadrants of the abdomen.This pain was aggravated or worsened by activity.She had severe pain with standing and walking that is in the left worse than right groin.The pain was also debilitating with rolling over in bed.She did undergo a left ilioinguinal nerve block which did not help her pain with walking but did help her pain when rolling over in bed.Today in clinic she describes the pain is a 6/10 that was a tightening aching both in her low back and her groin.To reduce her pain, she previously tried: physical therapy.L4-5 posterior decompression.Left ilioinguinal nerve block on (b)(6) 2021- this injection did not provide much benefit additional pain treatments including complementary medications other medications for pain.The assessment included lower abdominal pain, myofascial muscle pain, type 1 diabetes with hypoglycemia, and chronic right-sided low back pain without sciatica.The physician noted that as opposed to a frank hip or low back issue that this may be an abdominal issue, potentially secondary to her previous surgeries.The plan was to perform a left-sided q l 1 injection along with trigger point injections.Office visit on (b)(6) 2021: assessment: 1.Trochanteric bursitis of both hips.2.Tear of acetabular labrum.Chief complaint: hip pain.Associated symptoms include arthralgias, headaches, nausea, numbness, shortness of breath, frequency, back pain, nervous/anxious, sleep disturbance, gait problem, bruises/bleeds easily and urgency.Outside medical records were reviewed noting that she had bilateral hip pain and was referred to physical therapy.Was diagnosed with spondylosis and exam is most consistent with stenosis and started on physical therapy.She was also diagnosed with trochanteric bursitis of both hips and had very short-term relief of her symptoms with recent bursal injections.Recommended physical therapy and anti-inflammatories.Patient was also noted to have tear of acetabular labrum; and primary osteoarthritis of both hips, mild hip arthritis but they seem irritable on exam, no relief with intra-articular injections.It seemed like the pain was not with the hip joint, examination noted the pain was with prolonged standing or walking, thus, this might concern more with lumbar spine in nature.Office visit on (b)(6) 2022: assessment: 1.Abdominal pain, chronic, left lower quadrant the patient had a long history of chronic abdominal pain that has not responded to a diversity of therapeutic trials.She was likely a candidate for neuromodulation.Some areas of tenderness that did not recreate her primary pain problems.Her pelvic pain might not be the primary problem.Patient used a walker, wheelchair, or a cane depending on her pain.Took hydrocodone 6 a day prescribed by an endocrinologist and gabapentin 300 mg 4 times daily.Her primary pain was left side in the groin.This really affects her ability to walk and exercise.No sexual intercourse.Additional information received on august 15, 2023: on (b)(6) 2020, the patient was complaining of recurrent uti.She had eroded sling removed in february; however, experienced leaking all the time.She would like to talk to a physician regarding replacing of sling and possible propoxyphene antibiotic.On (b)(6) 2020, the patient had a follow-up from hospital for uti.She has already seen her immediate doctor and was told not to test urine and increase water.The patient confirmed she had urgency after sling removal as it was leaking while sitting and without coughing, sneezing, or exercising.The physician postponed the appointment and had the patient try a low dose of macrobid propoxyphene and myrbetriq.
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