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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Headache (1880); Incontinence (1928); Inflammation (1932); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Seroma (2069); Swelling (2091); Vomiting (2144); Weakness (2145); Tingling (2171); Cramp(s) (2193); Dysphasia (2195); Discharge (2225); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Injury (2348); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Neck Pain (2433); Post Operative Wound Infection (2446); Chest Tightness/Pressure (2463); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a transforaminal lumbar interbody fusion and posterolateral fusion from l5 to s1, during which rhbmp-2/acs was used.Reportedly, the patient¿s postoperative period was marked by severe pain to her lower back and bilateral extremities.
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Manufacturer Narrative
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(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on on (b)(6) 2012, (b)(6) 2010 patient presented for follow-up visit and reported low back pain.On (b)(6) 2011, (b)(6) 2010 patient presented for follow-up visit and reported sinus symptoms and hip pain and knee pain.On (b)(6) 2012 patient presented for follow-up visit and reported vomiting.On (b)(6) 2012 patient presented for follow-up visit and reported osteopenia.On (b)(6) 2012, (b)(6) 2011 patient presented for follow-up visit and reported progressive, dry cough, nasal congestion and nasal discharge.On (b)(6) 2012, (b)(6) 2011 patient presented for follow-up visit and reported vomiting.On (b)(6) 2012 patient presented for follow-up visit and reported chest pain.(b)(6) 2012 patient presented for follow-up visit with cough.On (b)(6) 2012, (b)(6) 2011, (b)(6) 2010 patient presented for follow-up visit.On (b)(6) 2013, (b)(6) 2012 patient presented for estradiol injection.On (b)(6) 2014 patient presented for follow-up visit and reported cough.It has been present for the past 10 weeks.Respiratory symptoms include chest congestion, progressive, productive cough, chest tightness, shortness of breath and wheezing other symptoms include chest congestion.Patient denies nasal congestion or nasal discharge.Sputum is described as scant and clear.She denies exposure to ill contacts.On (b)(6) 2014 patient presented for follow-up visit and reported cough.Respiratory symptoms included chest congestion and chest tightness.Other symptoms include chest congestion, subjective fever, frontal headache and sputum production patient denies exposure to ill contacts.Patient also reported ear pain.On (b)(6) 2014 patient presented for follow-up visit and reported chronic obstructive pulmonary disease.On (b)(6) 2014 patient presented for follow-up visit and reported neck pain.On (b)(6) 2014 patient presented for follow-up visit and reported cough.Respiratory symptoms included chest congestion and chest tightness.Other symptoms include chest congestion, subjective fever, frontal headache and sputum production patient denies exposure to ill contacts.Patient also reported ear pain.On (b)(6) 2015 patient presented for follow-up visit and reported low back pain.The discomfort is most prominent in the lumbar spine.This radiates to the radiation from the liver area.She characterizes it as constant, moderate in intensity, sharp, and aching.On (b)(6) 2014 patient presented for follow-up visit and reported cough.It had been present for the past one to two days.Respiratory symptoms included progressive, dry cough.Other symptoms include nasal congestion and nasal discharge.On (b)(6) 2015 patient presented for follow-up visit and reported neck pain and chronic neck pain.On (b)(6) 2015 patient presented for follow-up visit for depression.On (b)(6) 2015 patient presented for follow-up visit and reported cough for the past 2 weeks.Respiratory symptoms included chest congestion and chest tightness.Other symptoms include chest congestion, subjective fever, frontal headache and sputum production patient denies exposure to ill contacts.(b)(6) 2011 the patient presented with low back and right leg pain.X-ray of the complete spine was taken which showed decreased height of the c5-c6 disc space present with cervical straightening.Thoracic spine is normal.Bilateral l5 pars interarticularis defects present with grade-ii ventral slippage of the l5 vertebral body on the s1 vertebral body.Decreased height of l5-s1 disc space present.Questionable fracture of the l4 spinous process.Degenerated l5-s1 disc.Lumbar spine mri without contrast done on (b)(6) 2010 revealed 6 mm anterolisthesis of l5 on s1.There is bilateral spondylosis.There is endplate hypertrophy and disc material extruded to l5 neural foramina.With long decrease cranial caudal dimension related to anterolisthesis causes severe l5 neuro foraminal stenosis.Both s1 nerve roots are phased.There is also active modic changes in the endplates.(b)(6) 2012 the patient presented for consultation.Mri of the lumbar spine showed located in the posterior lower lumbar subcutaneous fat was a seromatous collection which extends from l3 level to s2 level.(b)(6) 2015 the patient presented with right-sided facial numbness, droop and also tingling and numbness in the upper and lower extremity.The patient also claims that she had some difficulty to speak and swallow and came to the emergency room for evaluation.(b)(6) 2011, patient also complained of recurrent headaches, nasal congestion and facial pain.Assessment: acute maxillary sinusitis; low back pain; idiopathic osteoporosis.(b)(6) 2011: the patient underwent x-ray of toe due to pain in left 4th toe.Impression: no evidence of acute bony traumatic pathology.(b)(6) 2011.Assessment: 1.Chronic low back pain related to degenerative lumbar spine disease.2.Right lumbar radiculopathy.3.Qu estionable l4 spinous process fracture.4.Myofascial pain syndrome.(b)(6) 2011, patient complained of low back pain as well as right lower extremity pain.The pain originated in her buttocks raised in the back of her thigh to the top of her foot.Assessment: 1.Chronic low back pain secondary to spondylosis and spondylolisthesis.2.Right lumbar radiculopathy.3.Myofascial pain syndrome.(b)(6) 2012: the patient presented for a follow-up visit.She complained of some intermittent calf numbness.She also had some back pain with numbness in the leg.(b)(6) 2012: the patient presented with low back pain.The pain was described as sharp, which radiated down both the legs.She also complained of numbness in legs.(b)(6) 2013: the patient presented with low back pain and medication management.(b)(6) 2013: the patient presented with pain symptoms prior to interventional treatment.Impression: failed back surgery syndrome/lu mbar post-laminectomy pain syndrome, low back pain, lumbar radiculopathy, chronic pain syndrome.(b)(6) 2013: the patient presented with the following preoperative diagnosis: failed back surgery syndrome/lumbar post-laminectomy pain syndrome, low back pain, lumbar radiculopathy, chronic pain syndrome.She underwent the following procedures: 1.L1-l2 inter-laminar lumbar epidural injection under fluoroscopic guidance.2.Epidurogram.No patient complications were reported.On (b)(6) 2014 assessment: neck pain; morbid obesity; low back pain.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2015: patient presented for medication refill.On (b)(6) 2015: patient presented for office visit.Patient complains of pain in lumbar.The patient describes her pain as constant with intermittent severities.The pain was aching, sharp, shooting, stabbing and tingling.The pain radiates to the bilateral lower extremities.The pain made worse bending, increased activity, lifting and movement.Review of systems: musculoskeletal: reports back and leg pain.Physical examination: lumbar spine: inspection within normal limits.Lumbar rom: limited ranges of motion due to pain on flexion, extension, lateral bending and rotational movements.Palpation: multiple trigger point areas palpated over posterior lumbar paravertebral bilaterally.Lumbar facet joint mid-low: pain/ tenderness illicited when palpating the mid-lower lumbar facet areas.Crepitation with rom negative.Assessment: failed back syndrome, lumbar; lumbar spine pain; coccyodynia; constipation due to pain medication.On (b)(6) 2015: patient presented for office visit with chief complaint of low back pain.Assessment: failed back syndrome, lumbar; bmi (b)(6), adult (b)(6) 2015; (b)(6) 2015: patient presented for medication refill.Assessment: lumbar failed back syndrome; myofacial pain/ fibromyalagia; bmi ((b)(6)).Patient underwent spm-trigger point injection.On (b)(6) 2015: patient presented for office visit with chief complaint of low back pain.Location: mid line with radiation into bilateral lower extremities.Assessment: lumbar failed back syndrome.On (b)(6) 2015: patient presented for office visit with chief complaint of low back pain.On (b)(6) 2015: patient presented for office visit with chief complaint of lumbago.Location: mid line lower lumbar area, with radiation across her lower back, into the hips, and buttock/gluteal area.Radiation into bilateral lower extremities.Pain was constant with intermittent severities.Pain was described as aching, pinching, shooting, numb and tingling.Pain was worsened by increased activity, bending and lifting.Review of system: musculoskeletal was positive for muscle spasms; mid and low back pain, hip pain, joint pain, neck pain, sciatica.Neurological: positive for numbness, weakness and tingling.On physical examination of lumbar spine, lumbar rom was limited due to pain on flexion, extension, lateral bending and rotational movements.Right and left lateral tilt decreased due to pain.Painful muscle knots noted indicating muscle spasms and trigger points.Multiple trigger points areas palpated over posterior lumbar paravertebral bilaterally.Pain/tenderness illicited when palpating the mid-lower lumbar facet areas.Exacerbation of low back pain on lumbar facet loading.Straight leg raising: positive bilaterally into both lower extremities for radicular parasthesias.Assessment: post laminectomy syndrome.On (b)(6) 2015: patient presented with pain in mid line lower lumbar area, with radiation across her lower back, into her hips and buttock/ gluteal area.Radiation into bilateral lower extremities.
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Event Description
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It was reported that the patient presented with the following preoperative diagnoses: grade 2 l5-s1 spondylolisthesis; l5-s1 herniated disk; lower back pain; bilateral lower extremity pain; failed conservative treatements.The patient underwent the following proce dures: l5-s1 partial corpectomy, microdiscectomy, interbody fusion, posterolateral arthrodesis, and posterior instrumentation; use of allograft and morcellized autorgraft; l5 gill-type laminectomy.Per the op notes, following endplate preparation, it was found due to significant spondylolisthesis, it did not appear that a cage placement was possible.A mixture of the rhbmp-2/acs and morcellized autograft bone was placed into the interspace at l5-s1 to achieve interbody fusion at the l5-s1 level.Next, a high speed midas rex drill was used to decorticate the sacral ala as well as the transverse process of l5.A mixture of morcellized autograft bone as well as rhbmp-2/acs was placed in the posterolateral gutters for the posterolateral arthrodesis.No patient complications were noted.Intraoperative x-rays were taken to confirm placement of hardware.Three weeks post-op, the patient underwent x-rays of the lumbosacral spine due to fall and to rule out fracture.Impression: very limited, no definite new fracture; status post posterior fusion l5-s1.Persistent subluxation which appears grossly stable l5-s1.The patient also underwent mri of the lumbar spine with and without contrast.Impression: post-operative changes involving the mid and lower lumbar spine paraspinal musculature and the subcutaneous regions.No definite epidural abnormality.
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Event Description
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It was reported that on, (b)(6) 2013 the patient was presented for office visit for evaluation of pain symptoms.Impression: lumbar radiculopathy with low back pain.The also underwent: bilateral l4-5 transforaminal epidural steroid injection; additional level: bilateral l5-s1 transforaminal epidural steroid injection; epidurogram.On (b)(6) 2013 the patient underwent trial of spinal cord stimulation under fluoroscopic guidance.Preoperative diagnosis: failed back syndrome/lumbar post laminectomy pain syndrome, low back pain, lumbar radiculopathy and chronic pain syndrome.On (b)(6) 2013 the patient was presented for office visit for follow up evaluation.Impression: failed back syndrome/ lumbar post-laminectomy pain syndrome, low back pain, lumbar radiculopathy, and chronic pain syndrome.On (b)(6) 2015 the patient was presented for office visit with lumbar spine and coccyx pain.Assessments: failed back syndrome.On (b)(6) 2015 the patient was presented for office visit with low back pain.Assessments: failed back syndrome.
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Manufacturer Narrative
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Add'l info: (b)(4).
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Event Description
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It was reported that on from 2003 to 2011, the patient was diagnosed with spondylolisthesis and herniated disk.On an unknown date in 2006, the patient was diagnosed with obstetrics and gynecology.From 2008 to present date, the patient was also diagnosed for difficulty breathing, speaking and swallowing, gastrointestinal problems, nerve injury.On (b)(6) 2011: the patient underwent mri lumbar spine.Impression: grade 1 anterolisthesis with pars articularis defect and disc degenerative disease and endplate hypertrophy and severe bilateral l5 neural foraminal stenosis and effacement of both s1 nerve roots.There are also active modic changes in the endplates.On (b)(6) 2011: the patient underwent mri lumbar spine without contrast.Impression: bilateral l5 pars interarticularis defects resulting in a grade 2 anterior spondylolisthesis with disc space narrowing and pseudo disc bulge contributing to severe foraminal narrowing and crowding of the transforaminal l5 nerve roots.No central l5-s1 spinal canal stenosis.On (b)(6) 2011: the patient went for an office visit.On (b)(6) 2011: the patient underwent ct thoracic spine without contrast.Impression: t9 mild superior endplate compression fracture which may be chronic, no obvious thoracic disc protrusion and no thoracic central canal or foraminal stenosis.Lumbar spine ct scan impression: 3 mm nonobstructing left renal calculus, l5-s1 bilateral spondylolysis grade 1 versus 2 spondylolisthesis and associated severe spondylosis with vacuum disc.Mild central canal narrowing in the lateral dimension and there is severe bilateral foraminal stenosis at this level.Ct scan cervical spine without contrast.Impression: neural foramen and central canal appear grossly patent.No spinal stenosis.X-ray lumbar spine 4views impression: maintained lumbar alignment, no spondylolisthesis.From an unknown date in 2012 tiil present date, the patient has been diagnosed with stroke, renal calculi and nerve injury.On (b)(6) 2012: the patient went for an office visit for follow up.On (b)(6) 2012: the patient presented with the following diagnosis: postoperative spinal wound infection, gastroesophageal reflux disease, elevated body mass index, tobacco abuse, anemia of chronic disease, candida vaginitis, treated.On (b)(6) 2012: the patient underwent chest one view x-ray impression: left picc line is seen tip in the superior vena cava.The heart size is normal.The lungs are clear of acute infiltrates.There is no pulmonary edema.There is no pleural fluid collection.On (b)(6) 2012: the patient presented with the following diagnoses: postoperative spinal wound infection.Gastroesophageal reflux disease.Elevated body mass index.Tobacco abuse.Anemia of chronic disease.Candida vaginitis, treated.On (b)(6) 2012: the patient went for a post op office visit due to postop wound infection.Impression: postoperative spinal wound infection.Gastro esophageal reflux disease.Elevated body mass index.Tobacco abuse.Anemia of chronic disease.On (b)(6) 2012: the patient underwent x-ray lumbar spine 2-3 views.Impression: maintained lumbar alignment, grade 2 spondylolisthesis l5-s1.On (b)(6) 2012: the patient went for an office visit due to low back pain and right leg pain.On (b)(6) 2012: the patient underwent x-ray chest pa and lat.Impression: no acute pulmonary disease.On (b)(6) 2012: the patient underwent mri lumbar spine with and without contrast.Impression: l5 parsinerarticularis defects with interim l5 laminectomies and placement of dorsal spinal fusion hardware transfixed by pedicle screws anchored within the bodies of the l5 and s1 vertebrae.There is severe disc space narrowing and grade 1 to 11 anterior spondylolisthesis contributing to severe chronic narrowing of the neural formainal and crowding of the transforaminal l5 nerve roots.On an unknown date in (b)(6) 2015, the patient underwent ultrasound and osteosarcoma myelosarcoma.Currently, the patient has the following problems: extreme pain, bladder incontinence, muscle spasms, implant site seroma, pain radiating down to legs, osteosarcoma, myelosarcoma, gastrointestinal problems, renal calculi, localized edema, nerve injury, mental anguish/depression.She also has complaints of numbness, tingling, pain in back and lower extremities, pain to hips, difficulty walking and standing for long periods of time.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2000: the patient presented with the following diagnosis: dizziness, pressure.On (b)(6) 2002: the patient underwent ultrasound of ¿ob¿ due to fetal age of unknown dates.Impression: single viable pregnancy at 8 weeks 1 day is present, 01/15/03 estimated date of confinement; the left ovary is visualized appearing unremarkable at 19x16x14 mm; not visualized right.On (b)(6) 2004: the patient presented with the complaints of: back pain, headache and vomiting.On (b)(6) 2005: the patient presented with right side abdominal pain.On (b)(6) 2006: the patient underwent x-rays of the chest due to cough.Impression: normal exam.On (b)(6) 2006: the patient was admitted with the following diagnoses: persistent pelvic pain, history of pelvic adhesions and previous laparoscopy.Also, she had a history of possible varicose veins in the pelvis.She underwent the following procedure: total abdominal hysterectomy and bilateral salpingo-oophorectomy.No patient complications were reported.The patient had the following postoperative diagnoses: pelvic pain, history of adhesions, and history of laparoscopy; possible endometriosis; possible adenomyosis.On (b)(6) 2006: the patient was discharged with the following diagnoses: persistent pelvic pain, history of pelvic adhesions and previous laparoscopy.Also, she had a history of possible varicose veins in the pelvis; total abdominal hysterectomy and bilateral s alpingo-oophorectomy.On (b)(6) 2006: the patient presented with abdominal pain.On (b)(6) 2006: the patient presented with back pain status post fall in shower.Impression: acute myofascial strain; lumbar pain.On (b)(6) 2006: the patient presented with back pain.On (b)(6) 2007: the patient was admitted to the emergency department with right hip pain and swelling due to a fall.She underwent x-ray of the hip which revealed possibility of a small chip off the superior aspect of the acetabulum.On (b)(6) 2007: the patient was discharged home in a stable condition.On (b)(6) 2007: the patient presented with right shoulder pain and swelling.Musculoskeletal examination revealed edema present at right shoulder.The range of motion of the right shoulder was limited.On (b)(6) 2007: the patient presented with complaints of dizziness, pain to right side of head behind right ear and bump behind right ear.On (b)(6) 2007: the patient presented with hip pain and swelling post a fall onto buttock.She also had complaints of back pain, frequent headaches and migraines.On (b)(6) 2007: the patient presented with abdominal pain.The patient underwent ct of abdomen and pelvis due to epigastric pain.Impression: no acute disease in the abdomen or pelvis; chronic pars defects at l5.On (b)(6) 2007: the patient presented to the emergency department with abdominal pain.She was admitted.The location of pain was epigastric and right upper quadrant, which radiated to the back.There were mitigating factors included analgesics and vomiting.She underwent ultrasound of abdomen.Impression: no visible upper abdominal disease.On (b)(6) 2007: the patient was discharged.On (b)(6) 2008: the patient presented with abdominal pain.The location of pain was the right flank and the right lower quadrant.She was also diagnosed for urinary tract infection.On (b)(6) 2008: the patient underwent ct of abdomen and pelvis due to right flank pain.Impression: no acute abnormalities; appendix is at the upper limits of normal in size with no significant periappendiceal inflammation; mild degenerative changes in spine.The patient was also discharged home.On (b)(6) 2008: the patient presented with abdominal pain.The location of the pain was epigastric and the right upper quadrant.Musculoskeletal examination revealed back pain and fibromyalgia.Neurologic examination revealed frequent headaches and migraines.On (b)(6) 2010: the patient presented with vaginal bleeding.She also complained of back pain.On (b)(6) 2010: the patient presented with left wrist sprain.She also complained of right hip pain.Impression: tendonitis, left wrist; right hip arthralgia.On (b)(6) 2010: the patient presented with left shoulder tenderness status post a fall.She underwent x-rays of the chest due to chest pain.Impression: mild stable cardiomegaly.She also underwent x-rays of the left shoulder due to shoulder pain.Impression: no radiographic evidence of fracture or dislocation.On (b)(6) 2010: the patient presented with chest pain ¿ pleuritic.On (b)(6) 2010: the patient presented with severe facial pain.The patient also had swelling and tenderness with chewing.She underwent ct maxillofacial due to pain.Impression: mildly enlarged right jugulodigastric lymph node which may be reactive to a regional i nfectious/inflammatory process; minimal mucosal thickening involving the maxillary sinuses which is nonspecific but may represent a mild chronic sinusitis.On (b)(6) 2010: the patient presented with concern for recurrent jaw pain.She underwent ct maxillofacial due to pain.Impression: prominent lymph nodes in the carotid chain bilaterally not significantly changed when compared to the prior study; mild mucoperiosteal thickening within the ethmoid sinuses.On (b)(6) 2010: the patient presented to the emergency department with low back pain and headache.Musculoskeletal examination revealed muscle pain.She underwent x-ray of the lumbosacral spine which revealed normal alignment, normal disc spaces and no fractures.On (b)(6) 2011: the patient presented with left wrist pain.The pain was reported to be in left lateral proximal area and was reported as radiating pain with associated decreasing ability to grip/strength.She underwent x-rays of the left wrist due to joint pain.Impression: no evidence for acute bony injury to left wrist; possible component of bony fusion between the third metacarpal and capitate which may be due to old trauma or congenital variant.On (b)(6) 2011: the patient presented with mild abdominal pain.The location of pain was epigastric.She was admitted to the emergency room.She also had complaints of nausea and vomiting.Cat scan was performed which revealed: mild wall thickening, proximal to the mid colon, suggesting infection with inflammatory colitis without surrounding inflammatory changes or free fluid; normal appendix; non obstructing renal stone, 2mm, collecting system stone at the lower pole on the left side.On (b)(6) 2011: the patient was discharged with the following diagnoses: acute viral gastroenteritis with diarrhea, resolved; peptic ulcer disease versus gastro-esophageal reflux disease.On (b)(6) 2012: the patient was admitted to the emergency department with abdominal and back pain.She also complained of vomiting.On (b)(6) 2012: the patient was discharged home in stable condition.On (b)(6) 2012: the patient was admitted with right upper quadrant abdominal pain.She also underwent ct of abdomen and pelvis.Impression: no acute findings within the abdomen or pelvis.On (b)(6) 2012: the patient was discharged.On (b)(6) 2012: the patient presented with complaints of cough, nasal congestion and malaise.Impression: upper respiratory infection.On (b)(6) 2012: the patient presented to the emergency department with complaint of migraine headache.The degree of severity was reported as mild.On (b)(6) 2012: the patient presented to the emergency department with abdominal pain.The pain was located in her right upper quadrant and radiating to her back.She also complained of right flank pain, nausea and vomiting.On (b)(6) 2013: the patient presented to the emergency department with nausea and/or vomiting.She also complained of some cramping.On (b)(6) 2013: the patient presented with left ankle twist and back pain.On (b)(6) 2013: the patient presented with migraine headache, photophobia, nausea and vomiting.On (b)(6) 2014: the patient was admitted with abdominal pain in the right lower quadrant.The pain radiated to right back and was described as aching, crampy and dull.The patient also complained of nausea.The patient underwent ct of abdomen and pelvis.Impression: no acute disease in the abdomen or pelvis; non-obstructing right renal calculus.On (b)(6) 2014: the patient was discharged.On (b)(6) 2014: the patient was admitted due to abdominal pain.The pain was in her most of epigastric right upper quadrant area.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis due to abdomen pain.Impression: no acute abnormality in abdomen and pelvis; left nephrolithiasis without visualized obstruction.The patient was discharged.On (b)(6) 2015: patient presented for office visit with diagnosis of copd, cough and neck pain.On (b)(6) 2015: the patient presented with complaints of vomiting, cough, ear plugged and headache.She underwent x-rays of the chest.Impression: no acute intra-thoracic findings.She also underwent ct of head.Impression: no acute intracranial findings; hypoplastic left mastoid air cells with scattered opacification may be result of chronic inflammation.On (b)(6) 2015: the patient presented with right upper abdominal pain, nausea, vomiting and diarrhea.The patient also complained of mid back pain status post slip and fall the previous night.The pain was reported to radiate out towards right back and flank.She underwent x-rays of the thoracic spine.Impression: negative thoracic spine.On (b)(6) 2015: the patient presented to the emergency room with the following diagnoses: right-sided facial numbness, droop and also t ingling and numbness in the upper and lower extremity.She was admitted for further evaluation and treatment.She also had complaints of chronic back pain, gastro-esophageal reflux, morbid obesity, chronic anemia and tobacco abuse.She underwent ct of head due to numbness.Impression: limited examination secondary to motion artifact; no acute intracranial process identified.On (b)(6) 2015: the patient underwent mri of brain due to right sided facial droop and history of leiomyoma/sarcoma.Impression: no acute intracranial process; no evidence of intracranial mass or mass effect.She also underwent bilateral carotid duplex ultrasound due to right face droop.Impression: no evidence for hemodynamically significant stenosis according to nascet criteria; there is 50-69% stenosis involving the left internal carotid artery.On (b)(6) 2015 the patient presented with right-sided facial numbness, droop and also tingling and numbness in the upper and lower extremity.The patient also claims that she had some difficulty to speak and swallow and came to the emergency room for evaluation.The patient was discharged home.On (b)(6) 2015: the patient presented with dog bite to left digit 2nd distal tip avulsion, abrasions to left lower abdomen.She underwent x-rays of the fingers due to dog bite to left second finger.Impression: suspect open tuft fracture off the distal phalanx of the left index finger with slight displacement of the distal fragment up to about 1 mm.She also underwent the following procedures: laceration repair.On (b)(6) 2015: patient presented for office visit with diagnosis of tia and depression with anxiety.On (b)(6) 2015: patient presented for office visit with diagnosis of copd, cough and depression with anxiety.On (b)(6) 2015: per billing records, the patient underwent the following procedures: lidocaine 10mg; ketorolac tromethamine 30mg.On (b)(6) 2015: the patient presented and complained of chest pain.The pain was sharp and stabbing.She was also confused and could not recall the events of the day.She was also diagnosed with: bacterial pneumonia, community acquired pneumonia and costochondritis.She underwent x-rays of the chest due to altered ¿loc¿.Impression: no acute abnormalities identified.She also underwent ct a of the chest due to shortness of breath and chest pain.Impression: no evidence for pulmonary embolus; linear bibasilar atelectasis with minimal patchy infiltrate in the upper lobes.An ultrasound venous doppler of bilateral lower extremities was also done due to bilateral lower extremity pain and swelling.Impression: no sonographic evidence for deep venous thrombosis within the bilateral lower extremity veins.On (b)(6) 2015: the patient presented with the following diagnoses: abdominal pain, diarrhea and vomiting.Abdominal pain was described as sharp and pressure.She underwent sodium chloride infusion procedure.She also underwent x-rays of the chest due to cough.Impression: stable chest x-ray.Nuclear medicine lung ventilation ¿ perfusion study was performed due to chest pain.Impression: low probability for pulmonary embolism.On (b)(6) 2015: the patient underwent ct of abdomen and pelvis due to nausea/vomiting and diarrhea.Impression: no acute disease; left renal stone.On (b)(6) 2016: per billing records, the patient underwent the following injection procedures: ketorolac tromethamine 30mg.
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Manufacturer Narrative
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(b)(4) ( persistent back pain).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on : (b)(6) 1996 the patient underwent abdominal and pelvic ultrasound due to lower abdomen pain.Conclusion: small, simple appearing cysts present within both ovaries, as described, with an otherwise unremarkable abdominal and pelvic ultrasound examination.On (b)(6) 1997, the patient was admitted with chief complaint of vaginal bleeding.On (b)(6) 1997, the patient presented for ultrasonography.On (b)(6) 1997, the patient was admitted with diagnosis r/o labor edc.On (b)(6) 1997, the patient was admitted due to nausea , vomiting , diarrhea.She was discharged on the next day.Assessment: acute g astroenteritis, dehydration and pregnancy (b)(6) 1999, the patient presented with pain in right ankle and underwent x ray examination.Impression: unremarkable right ankle.On (b)(6) 1999, the patient presented with complaint of lateral right ankle pain and x rays were reviewed.On (b)(6) 2000 the patient underwent obstetrical sonogram.Impressions: single live intrauterine pregnancy with an estimated gestational age of 26 weeks and 5 days, in breech presentation; borderline elevation of the head circumference to abdominal circumference ratio.On (b)(6) 2000: the patient presented with the following diagnosis: dizziness, pressure.On (b)(6) 2000, the patient presented with abdominal pain and vomiting and underwent laboratory evaluation.On (b)(6) 2001 the patient underwent obstetrical sonogram.On (b)(6) 2002: the patient underwent ultrasound of ¿ob¿ due to fetal age of unknown dates.Impression: single viable pregnancy at 8 weeks 1 day is present, (b)(6) 2003 estimated date of confinement; the left ovary is visualized appearing unremarkable at 19x16x14 mm; not visualized right.On (b)(6) 2002, patient presented with complaint of abdominal pain.On (b)(6) 2002, the patient presented with complaint of ruptured membranes.The patient underwent various lab evaluation.Clinical impression: soft tissue infection ¿cellulitis.On (b)(6) 2003, the patient was admitted with admitting diagnosis of active labor.The patient underwent medication and was discharged on (b)(6) 2003.On (b)(6) 2003 the patient underwent laparoscopic bilateral tubal ligation.Preoperative diagnosis: desire for permanent sterilization.Assessments: desires permanent sterilization.This will be done as a laparoscopic bilateral tubal ligation.All of the patient¿s questions were answered.She will be npo for eight hours prior to surgery; smoker.Has been encouraged to quit and not resume.On (b)(6) 2004: the patient presented with the complaints of: back pain, headache and vomiting.On (b)(6) 2005 the patient was presented for office visit with swelling to right lower thigh.On (b)(6) 2005: the patient presented with right side abdominal pain.On (b)(6) 2005, the patient underwent ct of abdomen and pelvis.Impression: normal appendix without evidence for appendicitis; mild colonic wall thickening versus underdiatention as described.A mild colitis cannot be excluded and clinical correlation is recommended.On (b)(6) 2005, the patient visited the facility.On (b)(6) 2005, patient presented in emergency department with complaint of pain and increasing swelling on right of face for four days.Ct scan of face showed extensive soft tissue swelling and cellulitis of right mandibular region.Constitutional: she has no fever, no chills, no weight change.Musculoskeletal: no back or joint pain.Neurological: no weakness or seizures.Nor slurred speech.On (b)(6) 2005, patient presented with complaint of painful selling on right side of face.Patient has history of infection on left side of face two months ago.On (b)(6) 2005, patient underwent exam for picc line insertion with sonographic and fluoroscopic guidance.Impression: successful insertion of a peripherally inserted central catheter line.On (b)(6) 2005, the patient presented with admitting diagnosis of cysts (b)(6) 2005, the patient presented with complaint of abscess at right underarm and bilateral groin.On (b)(6) 2005 the patient was presented for office visit.The patient reported ¿i woke up and started throwing up blood¿ nausea and pain.On (b)(6) 2006 the patient was presented for office visit with lots of pain, nausea and lightheaded.The patient underwent ct scan of the abdomen due to right lower quadrant pain.Impression: normal appendix without evidence for appendicitis; mild colonic wall thickening versus underdistention.A mild colitis cannot be excluded and clinical correlation is recommended.On (b)(6) 2006 the patient was admitted to the hospital.Impression: the patient has severe pelvic pain possibly ruptured ovarian cyst from the emergency room, possible endometriosis or adhesions, previous surgeries.She also might have adenomyosis and all of these diagnoses have been discussed with the patient.She understands the procedure and alternatives.The patient underwent operative laparoscopy with lysis of pelvic adhesions.Preoperative diagnosis: pelvic pain; pelvic adhesions.On (b)(6) 2006: the patient underwent x-rays of the chest due to cough.Impression: normal exam.On (b)(6) 2006: the patient was admitted with the following diagnoses: persistent pelvic pain, history of pelvic adhesions and previous laparoscopy.Also, she had a history of possible varicose veins in the pelvis.She underwent the following procedure: total abdominal hysterectomy and bilateral salpingo-oophorectomy.No patient complications were reported.The patient had the following postoperative diagnoses: pelvic pain, history of adhesions, and history of laparoscopy; possible endometriosis; possible adenomyosis.On (b)(6) 2006: the patient was discharged with the following diagnoses: persistent pelvic pain, history of pelvic adhesions and previous laparoscopy.Also, she had a history of possible varicose veins in the pelvis; total abdominal hysterectomy and bilateral s alpingo-oophorectomy.On (b)(6) 2006: the patient presented with abdominal pain.On (b)(6) 2006: the patient presented with back pain status post fall in shower.Impression: acute myofascial strain; lumbar pain.On (b)(6) 2006: the patient presented with back pain.On (b)(6) 2007: the patient was admitted to the emergency department with right hip pain and swelling due to a fall.She underwent x-ray of the hip which revealed possibility of a small chip off the superior aspect of the acetabulum.On (b)(6) 2007: the patient was discharged home in a stable condition.On (b)(6) 2007: the patient presented with right shoulder pain and swelling.Musculoskeletal examination revealed edema present at right shoulder.The range of motion of the right shoulder was limited.On (b)(6) 2007: the patient presented with complaints of dizziness, pain to right side of head behind right ear and bump behind right ear.On (b)(6) 2007: the patient presented with hip pain and swelling post a fall onto buttock.She also had complaints of back pain, frequent headaches and migraines.On (b)(6) 2007: the patient presented with abdominal pain.The patient underwent ct of abdomen and pelvis due to epigastric pain.Impression: no acute disease in the abdomen or pelvis; chronic pars defects at l5.On (b)(6) 2007: the patient presented to the emergency department with abdominal pain.She was admitted.The location of pain was epigastric and right upper quadrant, which radiated to the back.There were mitigating factors included analgesics and vomiting.She underwent ultrasound of abdomen.Impression: no visible upper abdominal disease.On (b)(6) 2007: the patient was discharged.On (b)(6) 2008: the patient presented with abdominal pain.The location of pain was the right flank and the right lower quadrant.She was also diagnosed for urinary tract infection.On (b)(6) 2008: the patient underwent ct of abdomen and pelvis due to right flank pain.Impression: no acute abnormalities; appendix is at the upper limits of normal in size with no significant periappendiceal inflammation; mild degenerative changes in spine.The patient was also discharged home.On (b)(6) 2008: the patient presented with abdominal pain.The location of the pain was epigastric and the right upper quadrant.Musculoskeletal examination revealed back pain and fibromyalgia.Neurologic examination revealed frequent headaches and migraines.On (b)(6) 2010: the patient presented with vaginal bleeding.She also complained of back pain.On (b)(6) 2010: the patient presented with left wrist sprain.She also complained of right hip pain.Impression: tendonitis, left wrist; right hip arthralgia.On (b)(6) 2010: the patient presented with left shoulder tenderness status post a fall.She underwent x-rays of the chest due to chest pain.Impression: mild stable cardiomegaly.She also underwent x-rays of the left shoulder due to shoulder pain.Impression: no radiographic evidence of fracture or dislocation.On (b)(6) 2010: the patient presented with chest pain ¿ pleuritic.On (b)(6) 2010: the patient presented with severe facial pain.The patient also had swelling and tenderness with chewing.She underwent ct maxillofacial due to pain.Impression: mildly enlarged right jugulodigastric lymph node which may be reactive to a regional infectious/inflammatory process; minimal mucosal thickening involving the maxillary sinuses which is nonspecific but may represent a mild chronic sinusitis.On (b)(6) 2010: the patient presented with concern for recurrent jaw pain.She underwent ct maxillofacial due to pain.Impression: prominent lymph nodes in the carotid chain bilaterally not significantly changed when compared to the prior study; mild mucoperiosteal thickening within the ethmoid sinuses.On (b)(6) 2010: the patient presented to the emergency department with low back pain and headache.Musculoskeletal examination revealed muscle pain.She underwent x-ray of the lumbosacral spine which revealed normal alignment, normal disc spaces and no fractures.On (b)(6) 2011: the patient presented with left wrist pain.The pain was reported to be in left lateral proximal area and was reported as radiating pain with associated decreasing ability to grip/strength.She underwent x-rays of the left wrist due to joint pain.Impression: no evidence for acute bony injury to left wrist; possible component of bony fusion between the third metacarpal and capitate which may be due to old trauma or congenital variant.On (b)(6) 2011: the patient presented with mild abdominal pain.The location of pain was epigastric.She was admitted to the emergency room.She also had complaints of nausea and vomiting.Cat scan was performed which revealed: mild wall thickening, proximal to the mid colon, suggesting infection with inflammatory colitis without surrounding inflammatory changes or free fluid; normal appendix; non obstructing renal stone, 2mm, collecting system stone at the lower pole on the left side.On (b)(6) 2011: the patient was discharged with the following diagnoses: acute viral gastroenteritis with diarrhea, resolved; peptic ulcer disease versus gastro-esophageal reflux disease.On (b)(6) 2012: the patient was admitted to the emergency department with abdominal and back pain.She also complained of vomiting.On (b)(6) 2012: the patient was discharged home in stable condition.On (b)(6) 2012: the patient was admitted with right upper quadrant abdominal pain.She also underwent ct of abdomen and pelvis.Impression: no acute findings within the abdomen or pelvis.On (b)(6) 2012: the patient was discharged.On (b)(6) 2012: the patient presented with complaints of cough, nasal congestion and malaise.Impression: upper respiratory infection.On (b)(6) 2012: the patient presented to the emergency department with complaint of migraine headache.The degree of severity was reported as mild.On (b)(6) 2012: the patient presented to the emergency department with abdominal pain.The pain was located in her right upper quadrant and radiating to her back.She also complained of right flank pain, nausea and vomiting.On (b)(6) 2013: the patient presented to the emergency department with nausea and/or vomiting.She also complained of some cramping.On (b)(6) 2013: the patient presented with left ankle twist and back pain.On (b)(6) 2013: the patient presented with migraine headache, photophobia, nausea and vomiting.On (b)(6) 2014: the patient was admitted with abdominal pain in the right lower quadrant.The pain radiated to right back and was described as aching, crampy and dull.The patient also complained of nausea.The patient underwent ct of abdomen and pelvis.Impression: no acute disease in the abdomen or pelvis; non-obstructing right renal calculus.On (b)(6) 2014: the patient was discharged.On (b)(6) 2014: the patient was admitted due to abdominal pain.The pain was in her most of epigastric right upper quadrant area.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis due to abdomen pain.Impression: no acute abnormality in abdomen and pelvis; left nephrolithiasis without visualized obstruction.The patient was discharged.On (b)(6) 2015: the patient presented with complaints of vomiting, cough, ear plugged and headache.She underwent x-rays of the chest.Impression: no acute intra-thoracic findings.She also underwent ct of head.Impression: no acute intracranial findings; hypoplastic left mastoid air cells with scattered opacification may be result of chronic inflammation.On (b)(6) 2015: the patient presented with right upper abdominal pain, nausea, vomiting and diarrhea.The patient also complained of mid back pain status post slip and fall the previous night.The pain was reported to radiate out towards right back and flank.She underwent x-rays of the thoracic spine.Impression: negative thoracic spine.On (b)(6) 2015: the patient presented to the emergency room with the following diagnoses: right-sided facial numbness, droop and also tingling and numbness in the upper and lower extremity.She was admitted for further evaluation and treatment.She also had complaints of chronic back pain, gastro-esophageal reflux, morbid obesity, chronic anemia and tobacco abuse.She underwent ct of head due to numbness.Impression: limited examination secondary to motion artifact; no acute intracranial process identified.On (b)(6) 2015: the patient underwent mri of brain due to right sided facial droop and history of leiomyoma/sarcoma.Impression: no acute intracranial process; no evidence of intracranial mass or mass effect.She also underwent bilateral carotid duplex ultrasound due to right face droop.Impression: no evidence for hemodynamically significant stenosis according to nascet criteria; there is 50-69% stenosis involving the left internal carotid artery.On (b)(6) 2015 the patient presented with right-sided facial numbness, droop and also tingling and numbness in the upper and lower extremity.The patient also claims that she had some difficulty to speak and swallow and came to the emergency room for evaluation.The patient was discharged home.On (b)(6) 2015: the patient presented with dog bite to left digit 2nd distal tip avulsion, abrasions to left lower abdomen.She underwent x-rays of the fingers due to dog bite to left second finger.Impression: suspect open tuft fracture off the distal phalanx of the left index finger with slight displacement of the distal fragment up to about 1mm.She also underwent the following procedures: laceration repair.On (b)(6) 2015: per billing records, the patient underwent the following procedures: lidocaine 10mg; ketorolac tromethamine 30mg.On (b)(6) 2015: the patient presented and complained of chest pain.The pain was sharp and stabbing.She was also confused and could not recall the events of the day.She was also diagnosed with: bacterial pneumonia, community acquired pneumonia and costochondritis.She underwent x-rays of the chest due to altered ¿loc¿.Impression: no acute abnormalities identified.She also underwent ct a of the chest due to shortness of breath and chest pain.Impression: no evidence for pulmonary embolus; linear bibasilar atelectasis with minimal patchy infiltrate in the upper lobes.An ultrasound venous doppler of bilateral lower extremities was also done due to bilateral lower extremity pain and swelling.Impression: no sonographic evidence for deep venous thrombosis within the bilateral lower extremity veins.On (b)(6) 2015: the patient presented with the following diagnoses: abdominal pain, diarrhea and vomiting.Abdominal pain was described as sharp and pressure.She underwent sodium chloride infusion procedure.She also underwent x-rays of the chest due to cough.Impression: stable chest x-ray.Nuclear medicine lung ventilation ¿ perfusion study was performed due to chest pain.Impression: low probability for pulmonary embolism.On (b)(6) 2015: the patient underwent ct of abdomen and pelvis due to nausea/vomiting and diarrhea.Impression: no acute disease; left renal stone.On (b)(6) 2016: per billing records, the patient underwent the following injection procedures: ketorolac tromethamine 30mg.
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