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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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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pulmonary Embolism (1498); Bronchitis (1752); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Fatigue (1849); Headache (1880); Itching Sensation (1943); Neuropathy (1983); Pain (1994); Pneumonia (2011); Sprain (2083); Swelling (2091); Thyroid Problems (2102); Vertigo (2134); Weakness (2145); Tingling (2171); Chills (2191); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Discomfort (2330); Arthralgia (2355); Depression (2361); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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Procedure: posterolateral lumbar fusion surgery levels implanted: l5-s1 it was reported that the patient underwent spine fusion surgery on the lumbar region at levels l5-s1.The patient was implanted with rhbmp-2 and collagen sponge which was applied from a posterolateral approach.The rhbmp-2 and collagen sponge was placed outside a cage (i.E.Along the facet joints and posterolateral gutters).Post-op, the patient complained of progressively worsening pain in her lower back, hips, and buttocks, with radiculopathy into her lower extremities.Patient still continues to experience chronic low back pain with severe pain and radiculopathy into her lower extremities.Patient experiences limited mobility due to difficulty balancing and walking and requires assistance when ambulating.Patient injuries prevented her from practicing daily life activities.
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.
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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 per patient's medical records that on: (b)(6) 2004: the patient presented with 80% bilateral leg pain, posterior buttock, posterior calf, posterior and 20% lumbosacral pain.Symptoms were aggravated by sitting, standing and walking.She underwent x-rays of lumbar spine which revealed no evidence of tumor, fracture or infection.On (b)(6) 2004: the patient underwent mri of lumbosacral spine due to bilateral low back and leg pain with tingling, numbness and weakness.Conclusion: small midline disc herniation at l5-s1 with mild to moderate underlying disc degeneration and with no stenosis or impingement; no intradural lesion seen and there is no neoplasm, fracture or infection.Examination of the lumbar spine is otherwise unremarkable except for a mild lumbar scoliosis apex to the left at l3.On (b)(6) 2004: the patient presented with chronic low back pain as well as pain in the lower extremities, particularly in the buttock and posterolateral thigh but also extended into the calf periodically.Mri was reviewed which revealed disc degeneration at the l5-s1 segment with high intensity zone tearing.On (b)(6) 2004: the patient presented with low back pain and bilateral leg pain.The patient underwent lumbar discography with therapeutic intradiscal injection of steroid and local anesthetic - one level.No patient complications were reported.On (b)(6) 2004: the patient presented with discogenic low back pain.On (b)(6) 2004: the patient underwent x-rays of the chest due to pre-op request by the surgeon.Impression: normal chest.On (b)(6) 2004: the patient presented with the following diagnosis: degenerative disc disease refractory non-operative care l5-s1.On (b)(6) 2004: the patient presented with the following pre-operative diagnosis: degenerative disc disease with stenosis, l5-s1.She underwent the following procedure: maverick total disc replacement with decompression, l5-s1.No patient complications were reported.On (b)(6) 2004: the patient called and reported bilateral low back pain, which was achy and sharp.The pain radiated into the left leg.On (b)(6) 2004: the patient presented for an office visit.She underwent unknown radiological study which revealed disc arthropathy to be in good position, no evidence of subsidence and no movement of the disc itself.On (b)(6) 2005: the patient presented for follow-up with periodic low back pain.On (b)(6) 2005: the patient presented with increasing severe leg pain, left lower extremity pain along with back pain.The patient underwent mri of lumbosacral spine due to bilateral low back and leg pain with tingling, weakness and numbness.Conclusion: postoperative disc replacement at l5-s1 with metallic artifact obscuring the central canal and neural foramen at this level; low signal intensity visualized within the superior aspect of the adjacent l5 vertebra on both t1-t2 weighted sagittal sections.Examination of the lumbar spine is otherwise unremarkable except for mild spondylosis at t11-12; no abnormalities visualized within the dural sac.On (b)(6) 2005: the patient presented with lumbar back pain.She underwent the following procedure: bilateral lumbar facet block at l5-s1.No complications were reported.On (b)(6) 2005: the patient underwent bilateral facet arthrogram with steroid and local anesthetic injection due to bilateral low back and lower extremity pain.Conclusion: there is left periarticular and right intraarticular dispersal of injected materials at the l5-s1 facet joints.Initial therapeutic response to injected local anesthetic is 50% left leg relief, no left buttock pain relief, and complete right back and leg pain relief (r1 on the left and r2 on the right).On (b)(6) 2005: the patient presented for a follow-up with pain in her left lower extremity.On (b)(6) 2005: the patient called and complained of bilateral low back pain.On (b)(6) 2005: the patient presented with severe low back pain.Ct scan and bone scan were reviewed which revealed subsidence into the endplate at l5; there was motion with flexion/extension radiographs.On (b)(6) 2005: the patient underwent "dexa" bone mineral density examination due to back pain.Impression: the patient's t-score meets the criteria for osteopenia at one or more measured sites.On (b)(6) 2006: the patient underwent two level lumbar discography due to bilateral low back pain.Conclusion: l4-5: normal disc discography.L3-4: non-concordant back pressure; essentially normal disc morphology.On (b)(6) 2006: the patient presented with severe back and leg pain.On (b)(6) 2006: the patient presented with the following pre-operative diagnosis: subsided maverick total disk prosthesis with chronic pain.She underwent the following procedures: minimally invasive posterior lateral arthrodesis, l5-s1.Bilateral legacy pedicle screw instrumentation, l5-s1.Left posterior ileum bone marrow harvest.Per the op notes, "a large rhbmp-2/acs kit was reconstituted for approximately 1 hour prior to its utilization.Of the larger kit, approximately one-sixth was placed into the facet joints bilaterally and the other five-sixth posterolaterally in a sandwich fashion on the allograft bone in several layers.The appropriate size rods were chosen and gentle compression was placed across the construct.In addition, the allograft bone marrow and rhbmp-2 mixture was packed into the facet joints.Prior to placement of the rhbmp-2, copious amounts of normal saline irrigation were utilized.The set screws were tightened to their specified torque.The quadrant retractors were removed." no patient complications were reported.On (b)(6) 2006: the patient presented for follow-up with worsening back pain.X-rays revealed good placement of the pedicle screws.The ap x-ray confirmed that the screw was in the pedicle and it was a question of a tilt.On (b)(6) 2006: the patient presented for follow-up with back pain.X-rays of the lumbar spine revealed stable position of the instrumentation with early consolidation of the posterolateral bone graft.On (b)(6) 2006: the patient presented for follow-up with flare of back pain, particularly left side around her incision.X-rays of the lumbar spine revealed stable position of all the implants as well as what appeared to be continued incorporation of the posterolateral graft.There was no evidence of instrumentation loosening.On (b)(6) 2006: the patient presented for follow-up.She felt like there was a lump in her left eye.On (b)(6) 2006: the patient presented with chronic pain.On (b)(6) 2006: the patient presented for follow-up of chronic low back pain.On (b)(6) 2006: the patient presented with pneumonia follow-up.She had complaints of fatigue, abdominal pain and fever.She felt short of breath and had stomach ache.She also had some diarrhea alternating with constipation.Ct scan of the chest, abdomen and pelvis were done which revealed right upper lobe infiltrate with some right peripheral adenopathy.Assessment: right upper lobe pneumonia.Ovarian cyst.Leukocytosis.Hyponatremia.On (b)(6) 2007: the patient presented for follow up pneumonia.On (b)(6) 2007: the patient presented with bilateral ovarian cyst.On (b)(6) 2007: the patient presented prior to laparoscopy for bilateral complex ovarian cysts.Assessment: pre-operative evaluation prior to laparoscopic bilateral salpingo-oophorectomy.On (b)(6) 2007: the patient underwent laparoscopic bilateral salpingo-oophorectomy.No complications were reported.On (b)(6) 2007: the patient presented for follow-up, with no acute complaints.On (b)(6) 2007: the patient presented with increased symptoms.She had noticed sensation of fevers and chills.Chest x-ray was performed which was normal.Assessment: upper respiratory symptoms consistent with acute bronchitis.On (b)(6) 2007: the patient presented for follow-up.Assessment: stable and satisfactory postoperative course.On (b)(6) 2007: the patient presented with chronic back pain.She also had pain in both legs.On (b)(6) 2007: the patient presented for follow-up of depression as the pain had not improved.She also had a little stiffness in her hands.On (b)(6) 2007, on (b)(6) 2008: the patient presented with low back pain and pain in both legs.The distribution of the pain in the lower limbs was posterior thigh, posterior leg and soles of both feet.She also had numbness and tingling in the lower limbs.She had weakness in left lower limb.The back pain was burning, deep aching, stabbing and sharp.Assessment: chronic lower back pain and bilateral lower limb radicular pain mostly in s1 dermatomal distribution bilaterally.Bilateral lumbar facet joints arthropathy.Bilateral sacroiliac joint dysfunction.Left trochanteric bursitis.Right rotator cuff syndrome, right bicipital tendonitis.On (b)(6) 2008: the patient presented with severe low back pain radiating down her legs, her hips and buttocks.On (b)(6) 2008: the patient presented for pre-operative evaluation prior to implantation of a spinal cord stimulator.Her trial period yielded great results.On (b)(6) 2008, (b)(6) 2009: the patient presented for follow-up with chronic low back pain.She also had bilateral leg and buttock pain after a fall on the ice several years ago.On (b)(6) 2009: the patient presented for medication refill.On (b)(6) 2009: the patient presented for follow-up with chronic low back pain.She also had bilateral leg and buttock pain.Assessment: chronic pain.Insomnia.Osteoporosis.On (b)(6) 2009: the patient presented for bone mineral density evaluation.On (b)(6) 2009: the patient presented with difficulty with symptoms that she described as heightened sensitivity or heightened awareness of sensations.On (b)(6) 2009: the patient presented for follow-up due to chronic narcotics.On (b)(6) 2009: the patient presented for follow-up.Assessment: stable and satisfactory postoperative course.On (b)(6) 2010: the patient presented for routine health maintenance.She still had problems of chronic low back pain.On (b)(6) 2010: the patient presented for pre-operative evaluation prior to replacing the wires in her spinal cord stimulator.On (b)(6) 2010: the patient presented post replacement of the leads for her spinal cord stimulator.Assessment: chronic back pain.Tobacco abuse.Hypothyroidism.On (b)(6) 2010: the patient presented with refill of her pain medications.Assessment: chronic pain syndrome.On (b)(6) 2010: the patient presented with pain involving her upper back, neck, middle and lower back with pain into both lower extremities.She also suffers with occasional headaches.Assessment: intractable pain syndrome, cervical, thoracic and lumbar spinal pain with myofascial elements.Cervical spine pain with upper extremity symptoms.Lumbar spine surgeryx2 with ongoing pain.Lumbar spine pain with lower extremity symptoms.Mixed headaches, cervicogenic/ tension type headache.Depression secondary to ongoing pain and loss of function.Sleep disturbances secondary to ongoing pain.On (b)(6) 2010: the patient presented to evaluate her ongoing treatment program and pain complex.Assessment: intractable pain syndrome, cervical, thoracic and lumbar spinal pain with myofascial elements.Cervical spine pain with upper extremity symptoms.Lumbar spine surgeryx2 with ongoing pain.Lumbar spine pain with lower extremity symptoms.Mixed headaches, cervicogenic/ tension type headache.Depression secondary to ongoing pain and loss of function.Sleep disturbances secondary to ongoing pain.On (b)(6) 2010: the patient presented with right shoulder pain.Diagnoses: acute right shoulder sprain; thoracic back pain and myofascitis; chronic pain disorder.On (b)(6) 2010: the patient presented with edema.She reported that over two months, her feet and calves had been more swollen.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, (b)(6) 2013: the patient presented for assessment of herb medical pain management program.She has required treatment for low back pain, pain into both lower extremity as well as generalized pain in the upper body and extremities.On (b)(6) 2011: the patient presented with several concerns.She was being evaluated for fibromyalgia.She continued to have chronic back pain.Assessment: tobacco cessation.Chronic pain.Major depression, moderate, recurrent.Insomnia.Hypothyroidism.(b)(6) 2011: the patient presented with neck and shoulder pain, low back pain, pain in forearms, lateral thighs and knees.She also had numbness in the feet.Assessment: diffuse myofascial pain; chronic pain syndrome.(b)(6) 2011: the patient presented to evaluate her ongoing treatment program and pain complex.She required treatment for low back pain, pain into both lower extremities.She also experiences diffuse pain associated with fibromyalgia syndrome.(b)(6) 2011: the patient presented with complaint of stabbing right-sided flank and lower chest pain, worse with deep inhalation and sometimes with movement.The patient also felt chills and had some headache and dizziness.The patient underwent x-ray of chest.On (b)(6) 2011: the patient presented for evaluation of bone density.Assessment: moderate low bone density based on the lowest t-score, which was at the forearm and femoral neck.On (b)(6) 2011: the patient presented to evaluate her ongoing treatment program and pain complex.She has required treatment for low back pain, pain into both lower extremities.She has a spinal cord stimulator in place.She reports experiencing sharp pains around this site, feels like electrical shock.This occurred when the stimulator was turned off.On (b)(6) 2011: the patient presented with dyspnea, which started two days ago and had become progressively worse.On (b)(6) 2011: the patient presented for follow-up with shortness of breath and some pleuritic chest pain.A ct pulmonary angiogram showed some extensive pes with clot present bilaterally multiple moderate and small primarily central emboli in both lungs.On (b)(6) 2011: the patient presented for follow-up.Assessment: chronic pain syndrome.Hypoxemia following extensive pulmonary embolism.Tobacco abuse.On (b)(6) 2011: the patient presented with complaints of dizziness and headache.Assessment: dizziness with new mild shortness of breath, calf tenderness, recent pe and tobacco use.On (b)(6) 2011: the patient presented to evaluate her ongoing treatment program and pain complex.She required treatment for neck pain, low back pain, pain into both lower extremities.She has been having headaches with dizziness, fatigue, and has multiple pulmonary emboli area.On (b)(6) 2011: the patient presented for follow-up of just not feeling well.Assessment: dyspnea.General unwellness.Insomnia.On (b)(6) 2011: the patient presented for pre-operative evaluation prior to cataract surgery.She had progressively difficulty with vision and had been diagnosed with cataracts.On (b)(6) 2011: the patient presented to evaluate her ongoing treatment program and pain complex.She required treatment for low back pain, pain into both lower extremities.She has been having difficulty with pain involving the left side with pain wraps into the left groin area.On (b)(6) 2011: the patient presented for evaluation of dyspnea.Assessment: mild chronic obstructive pulmonary disease.On (b)(6) 2011: the patient presented for evaluation of: red spots on face and chest; brown spots on cheeks; brown spots on shoulders; rough spot on left knee; spots under breasts.Assessment: neoplasm etiology unknown.Irritated "seb ker" on left inner knee.Benign nevus, "seb kers, and lentigines." (b)(6) 2011: the patient presented with chronic pain.She continued to feel some dizziness if she bended or turned her head.Assessment: dyspnea, mild.Benign paroxysmal positional vertigo.History of massive bilateral pulmonary embolism.Hypothyroidism.On (b)(6) 2012: the patient presented for follow-up.Assessment: recurrent pulmonary embolism.On (b)(6) 2012: the patient presented for evaluation of left proximal humerus fracture, suffered on (b)(6) 2012.X-rays were taken due to proximal humerus fracture, which showed significant increase in callus formation.On (b)(6) 2012: the patient presented for follow-up of her left proximal humerus fracture.She underwent x-rays of the pelvis and hips which showed presence of her spinal cord stimulator, disk replacement and lumbar fusion; no overwhelming degenerative changes seen in the hips.Assessment: left proximal humerus fracture healing.Hip pain.Left knee pain.She underwent x-ray of shoulders and left knee (b)(6) 2012: the patient presented for a follow-up of acute chronic low back pain.On (b)(6) 2012: the patient presented for an office visit.On (b)(6) 2012: the patient presented with concerns regarding infection.Assessment: no obvious infection.She underwent x-ray of chest.On (b)(6) 2012: the patient presented for pre-operative evaluation for removal or spinal cord stimulator.She had spinal cord stimulator placed which was now non-functional.On (b)(6) 2012: the patient presented with swallowing difficulty.On (b)(6) 2013: the patient presented to evaluate her ongoing treatment program and pain complex.She required treatment for low back pain, pain into both lower extremities.She suffers from fibromyalgia and chronic fatigue syndrome.She had pain in both hips and both knees, left worse than right.She has been proposed surgery, hemiarthrodesis.She was concerned about just doing half of the knee.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: the patient presented for evaluation of her medical pain management.On (b)(6) 2013: the patient presented for pre-operative evaluation prior to laser eye surgery.On (b)(6) 2013: the patient presented with allergic reaction due to fake eyelashes, which started to get kind of red, swollen and itchy.On (b)(6) 2013: the patient presented to evaluate her ongoing treatment program and pain complex.She has required treatment for low back pain, pain into both lower extremities.On (b)(6) 2013: the patient presented with concerns about lyme disease.She had some swelling in her knee and ankle.Assessment: history of possible tick exposure.Hypothyroidism.History of abnormal mole.On (b)(6) 2013: the patient presented with knee swelling and pain.She gained about 40 pounds over the last two years.Assessment: monoarthritis of knee.Chronic pain syndrome.Arthralgia.On (b)(6) 2013: the patient presented for follow-up.Assessment: skin flushed (782.62) pneumonia, organism unspecified (486).She underwent x-ray of chest.On (b)(6) 2013: follow up on knee swelling and pain.The patient returns for follow up, seen on (b)(6) 2013 for monoarthritis of the left knee.She was given an injection with triamcinolone acetate.She stated that the next day she developed significant flushing of her face and anterior chest, no wheezing, chest pain, cough, tongue or lip swelling.Since her left knee swelling and pain has significantly improved.She denies any swelling today.Assessment: swelling of right knee joint.Adverse drug reaction.On (b)(6) 2013: the patient presented to evaluate her ongoing treatment program and pain complex.She has required treatment for low back pain, pain into both lower extremities.She suffers from fibromyalgia and chronic fatigue syndrome.She has pain in both hips.On (b)(6) 2013: the patient presented with evaluation of some changing moles on her trunk and face.On (b)(6) 2013: follow up on knee swelling.She stated that since her last visit, the left knee has been progressively swelling slowly over the last one month.She noted pain especially with walking, crouching down or when up and down steps.On (b)(6) 2014: the patient underwent left knee arthroscopic procedure.On (b)(6) 2014: after 14 days of left knee arthroscopy pmm, pain was controlled with current analgesics.Post op problems were reported: none (b)(6) 2014: the patient presented for follow up.Her chief complaint was right-sided low back pain that is extended into the buttock region.On (b)(6) 2014: the patient presented for post op follow up at the 6 week mark after surgery.She continued to have quite severe axial back pain.Assessment: ongoing symptoms (b)(6) 2014: the patient presented for evaluation of possible bug bites to her upper thighs, buttocks and under her bilateral breast areas.She noted that the sores were itchy.She instructed to take cetirazine daily and discharged ambulatory and in stable condition.On (b)(6) 2014: the patient presented with the problem of cough from 5 days and fever today.She underwent copd exacerbation (hcc) but no obvious infiltrate were observed on the x- ray.She had given some medicines.On (b)(6) 2014: the patient was presented with cough as a chief complaint.Clinical impression: viral syndrome.
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Event Description
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It was reported that on (b)(6) 2006: the patient underwent ct of lumbar spine status post l5-s1 fusion with low back and bilateral leg pain.(b)(6) 2006: the patient underwent image study.(b)(6) 2007: per billing records patient underwent x-ray exam of lower spine complete.(b)(6) 2009: per billing records patient underwent x-ray exam of lumbar spine min.4 views.
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Event Description
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It was reported that on, (b)(6) 2008: patient underwent epidural steroid injection via the posterior interlaminar approach at the following spinal level: l4-5.The procedure was performed with fluoroscopic guidance.Patient tolerated the procedure well with no complications reported.On (b)(6) 2008: patient presented with complaint of pain in the lower back on bilateral sides.On (b)(6) 2009: patient presented with complaint of pain in the lower back on bilateral sides along with complaint of pain in legs and the right shoulder.On (b)(6) 2010: patient presented for post-op wound evaluation and to meet with "ans" to have her stimulator turned on and programmed.On (b)(6) 2011: patient presented for management of persistent pain in the lower back.Diagnosis: lumbago; myalgia and myositis.On (b)(6) 2012: patient presented for postoperative wound check following removal of her st jude's stimulator system a week ago.
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Event Description
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It was reported that on (b)(6) 2009, the patient was presented for office visit with chronic pain.Assessments: depression.Chronic pain.On (b)(6) 2009, the patient was presented for office visit with chronic pain.Assessments: chronic back pain.On (b)(6) 2009, the patient was presented for office visit with chronic pain.Assessments: chronic pain syndrome.Osteoporosis.Hypothyroidism.On (b)(6) 2009, the patient was presented for office visit with chronic pain.Assessments: chronic pain syndrome.Routine health maintenance.On (b)(6) 2009, the patient was presented for office visit with chronic pain.Assessments: preoperative evaluation prior to implantation of leads for her spinal cord stimulator.Chronic pain management.On (b)(6) 2009, the patient was presented for office visit with chronic pain.Preoperative evaluation.Chronic pain, restoril prescription, chronic pain.On (b)(6) 2010, the patient was presented for office visit for post operative evaluation and spinal cord stimulator programming.On (b)(6) 2010, the patient was presented for office visit.Impression: major depressive disorder, generalized anxiety disorder, panic disorder without agoraphobia, lumbosacral disc degeneration, thoraco-lumbar radiculopathy.On (b)(6) 2010, the patient was presented for office visit to evaluate her ongoing treatment program and pain complex.She continues to require pain associated with her lower back with pain into both lower extremities.Assessments: intractable pain syndrome, cervical, thoracic, and lumbar spinal pain with myofascial elements, cervical spine pain with upper extremity symptoms, lumbar spine surgery x2 with ongoing pain, lumbar spine pain with lower extremity symptoms, mixed headaches, cervicogenic/tension type headaches, depression secondary to ongoing pain and loss of function, sleep disturbances secondary to ongoing pain.On(b)(6) 2010, the patient was presented for behavioral health evaluation.Diagnostic impression: pain disorder associated with both psychological factors and a general medical condition, deferred, bilateral low back pain.On (b)(6) 2010, the patient was presented for office visit with ongoing management of persistent pain.The patient reported pain in the lower back on bilateral sides.The patient also reported pain in the legs and the right shoulder.Diagnosis: lumbar radicular pain.Degenerative disc disease involving one or more lumbar discs.Thoraco-lumbar radiculopathy.On (b)(6) 2011: the patient presented for assessment of herb medical pain management program.She has required treatment for low back pain, pain into both lower extremity as well as generalized pain in the upper body and extremities.On (b)(6) 2011: patient underwent cta pulmonary embolism study iv contrast.Impression: numerous bilateral pulmonary emboli are seen in the lobar branches supplying all lobes of both lungs.The emboli have a central predominance with many distal segmental and subsegmental branches remaining patent and opacifying with contrast.No area of acute consolidation in lungs.There is an area of stable scarring and interstitial thickening in the left upper lobe.Patient underwent x-ray of chest.Impression: mild pulmonary vascular congestion.The lungs are clear.On (b)(6) 2011, patient underwent ultrasound venous duplex extremity lower right.Impression: negative right lower extremity venous duplex ultrasound with no evidence of deep venous thrombosis.Small calf vein thrombosis cannot be completely excluded by this technique.On (b)(6) 2011, patient presented in emergency department with complaints of dizziness with bending over and standing up.Patient reported double vision, numbness in feet.Patient underwent ct scan of head with and without iv contrast.Impression: essentially unremarkable ct of head.No acute intracranial hemorrhage; 6mm soft tissue density near pituitary fossa and sphenoid sinus is favored reflect a pituitary gland itself and is grossly stable from prior.Sphenoid sinus mucous cyst felt less likely.On (b)(6) 2011: patient underwent cta pulmonary embolism study iv contrast.Impression: when compared to(b)(6) 2011, previous bilateral pulmonary emboli have resolved.No acute pe on todays examination.On (b)(6) 2011, patient presented for follow-up visit for dyspnea.On (b)(6) 2011: patient underwent ct of abdomen and pelvis with iv contrast.Impression: impression: fatty infiltration of the liver; new very mild splenectomy.Non-specific; otherwise unremarkable ct of abdomen and pelvis.On (b)(6) 2011, (b)(6) 2012, patient presented for evaluation of pain involving upper, middle and lower back, with pain radiating into both lower extremities.On (b)(6) 2011, patient was presented in emergency department with complaint of progressively worsening shortness of breath.Patient underwent cta pulmonary embolism study iv contrast.Impression: no significant change since (b)(6) 2011.Negative for acute pulmonary embolism; unchanged patchy ground glass opacities in the left upper lobe.There are no acute pulmonary opacities.Patient under went x-ray of chest.Impression: clear chest.No significant change since (b)(6) 2011.On (b)(6) 2012, patient was presented in emergency department with complaint of shortness of breath.Patient underwent cta pulmonary embolism study iv contrast.Impression: new extensive bilateral pulmonary embolism since (b)(6) 2011.On (b)(6) 2012, patient presented for follow-up for humerus fracture and underwent x-ray of left shoulder.On (b)(6) 2014, patient presented for office visit with complaint of throbbing pain, sharp and shooting pain, dull and achy pain on lower back.Pain increases with bending, lifting, sitting, and standing, walking or running.Patient reported decreased function, loss of balance, decreased strength, radiating pain: sciatic down both legs.Patient also reported sharp and shooting pain, dull and achy pain on bilateral neck.Pain is aggravated by looking over shoulder, lifting and sitting.Patient reported pins and needles into arms, radiating pain: forearm bilaterally.Review of system: neurological: fatigue; psychiatric: depression; musculoskeletal: neck pain and back pain.On (b)(6) 2014, patient presented for office visit with complaint of throbbing pain, sharp and shooting pain, dull and achy pain on lower back.Pain increases with bending, lifting, sitting, and standing, walking or running.Patient also reported sharp and shooting pain, dull and achy pain on bilateral neck.Pain is aggravated by looking over shoulder and sitting.Review of system: neurological: fatigue; psychiatric: depression.On (b)(6) 2014, patient presented for office visit with complaint of throbbing pain, sharp and shooting pain, dull and achy pain on lower back.Pain increases with bending, lifting, sitting, and standing, walking or running.Also there was radiating pain and bilateral toe numbness.Patient also reported sharp and shooting pain, dull and achy pain on bilateral neck.Pain is aggravated by looking over shoulder and sitting.Review of system: neurological: fatigue; psychiatric: depression.On (b)(6) 2015, patient presented for office visit with complaint of throbbing pain, sharp and shooting pain, dull and achy pain on lower back.Pain increases with bending, lifting, sitting, and standing, walking or running.Also there was radiating pain and bilateral toe numbness.Patient also reported sharp and shooting pain, dull and achy pain on bilateral neck.Pain is aggravated by looking over shoulder and sitting.Patient reported sharp and shooting pain on left side of rib for several days, which aggravates with deep breathing.On (b)(6) 2015, patient presented for office visit with complaint of throbbing pain, sharp and shooting pain, dull and achy pain on lower back.Pain increases with bending, lifting, sitting, and standing, walking or running.Also there was radiating pain and bilateral toe numbness.Patient reported decreased function, loss of balance, decreased strength, radiating pain: sciatic down both legs.Patient also reported stiffness bilateral neck.Pain is aggravated by looking over shoulder and sitting.
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Event Description
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It was reported that on, (b)(6) 2016: the patient presented for re-evaluation of medical pain management program and pain complex.
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Event Description
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It was reported that on (b)(6) 2007: patient presented with chronic back pain and medication management.(b)(6) 2015: patient presented with an office visit due to fever and cough.Assessment: left lower lobe pneumonia.On (b)(6) 2015: patient presented for concerns about pneumonia.On (b)(6) 2016: patient presented with a follow-up visit due to worsening nerve pain.Assessment: chronic neuropathic pain.Dermatology consult required for concern of skin cancer.Right knee discomfort.Hypothyroidism.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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