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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 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Cyst(s) (1800); Dyspnea (1816); Fatigue (1849); Hyperplasia (1906); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Dizziness (2194); Stenosis (2263); Urinary Frequency (2275); Injury (2348); Joint Swelling (2356); Malaise (2359); Depression (2361); Numbness (2415); Neck Pain (2433); Breast Mass (2439); Palpitations (2467); Sleep Dysfunction (2517); No Code Available (3191)
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Event Type
Injury
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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.
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Event Description
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It was reported that on (b)(6) 2011, the patient presented with the following pre-op diagnosis: left l5-s1 acute radiculopathy status post remote left- sided transforaminal lumbar interbody fusion (tlif) with instrumentation.Failed fusion l5-s1.The patient underwent: revision decompression left l5-s1 nerve roots.Extensive adhesiolysis, neuralysis left l5-s1 nerve roots.Explanation hardware bilateral l5-s1.Re-implantation of 3d tsrh transpedicular screws with bilateral inter-transverse fusion using autograft, bone graft and rhbmp-2/acs.As per op notes, at first ap and lateral fluoroscopy views were performed prior to incision.The pedicle screws were replaced at l5 and s1 bilaterally and placed the foramen under slight distraction.The proximal portion of the previously placed graft was seen, drilled and flushed with disc space.Intra-op findings: bony spicules and calcified ligament was present that were contributing to the compression of the s1 and l5 nerve roots.The screws were placed on the right side as well; they were all 0.5 mm larger in diameter.At s1 the screws were 1 cm shorter.These were the 3d tsrh type screws.The screws were then connected to a 3.5 cm titanium rod with small offset connectors.A torque/counter - torque device was used to fix the screws to the rods.X-rays confirmed nice placement and length of the screws/rod complex.The intertransverse interval then was covered with one single piece of infuse bilaterally covered by autograft morselized from the revision decompression, as well as bone graft.The patient had following complication: postoperative anemia.On (b)(6) 2011: the patient presented for postoperative follow up.On (b)(6) 2011: the patient was discharged in good spirits with improved h <(>&<)>h.On (b)(6) 2012, the patient presented with intense numbness that wraps around her left hips to her groin and all the way down to her left foot.On (b)(6) 2012, patient came for a post-op visit with considerable pain and dysfunction of the left leg in the l5 and s1 distributions.The musculoskeletal review: back pain, leg pain, joint pain and joint swelling.Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Impression: residual left s1 radiculopathy, stable s/p alif with no improvements in symptoms, stable s/p posterior decompression and fusion l5-s1.On (b)(6) 2012, the patient underwent ct of the lumbar spine with 3d construction.Opinion: interval revision of operative changes at l5-s1.Otherwise negative noncontrast ct of the lumbar spine.On (b)(6) 2012, the patient came for a follow-up visit post-op posterior decompression and revision fusion for an l5-s1 pseudo arthrosis.Recent ct shows a nicely maturing fusion and an emg shows partial healing of the left l5 and s1 nerve roots.L5 has healed completely but s1 now shows both an acute and chronic injury.The musculoskeletal review: leg pain and leg weakness.Neurological review: balance problem and numbness.Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Stable s/p alif with no improvements in symptoms.Stable s/p posterior decompression and fusion l5-s1.Impression: residual left s1 radiculopathy.On (b)(6) 2012: the patient presented with the following preoperative diagnosis: failed l5-s1 fusion with alif and posterior revision.History of left l5 and s1 radiculopathies.The patient underwent the following procedures: intravenous sedation.Fluoroscopy.Left s1 transforaminal epidural steroid injection with steroid.No complications were reported.On (b)(6) 2012: the patient presented for an office visit.Impression: menometrorrhagia, etiology unclear.History of endometrial polyp positive d<(>&<)>c and polypectomy.The patient underwent hysterectomy.On (b)(6) 2012: the patient was discharged with following diagnosis: menometrorrhagia.Anemia of acute blood loss.On (b)(6) 2012, as per medical records, the musculoskeletal review: present-back pain, leg pain and leg weakness.Neurological review: balance problem and numbness (left leg and right ankle).On (b)(6) 2012, the patient underwent radiographic study of lumbar spine.Opinion: stable post-op change s in the lumbar spine and mild disc space narrowing at l4-5.On (b)(6) 2012, the patient presented with back pain which is mechanical in nature and radicular features in her leg pain.Musculoskeletal review: present-back pain, leg pain and leg weakness.Neurological review: balance problem and numbness (left leg and right ankle).Assessment: failed fusion l5-s1 with residual left l5, s1 radiculopathies.Stable s/p alif with no improvements in symptoms.Stable s/p posterior decompression and fusion l5-s1.Impression: residual left s1 radiculopathy, new rle and low back symptoms.Rec.Ct/mri rule out failed fusion or asd.On (b)(6) 2012, the patient underwent ct of the lumbar spine with 3d reconstructions; mri of the lumbar spine w <(>&<)> w/o contrast due to low back pain, left leg numbness.History of fusion.Lumbar spine ct opinion: essentially stable post-op changes in the lumbar spine.Interval hysterectomy and development of a large left ovarian cyst.Lumbar spine mri opinion: tiny left lateral disc herniation at l4-5.Post-op changes.Left ovarian cyst.Otherwise negative contrast/ noncontrast mri of the lumbar spine.On (b)(6) 2012: the patient presented with posterior si joint area pain as well as persistent pain and weakness in the left lower extremity.The patient remained very emotional, crying frequently.Review of systems showed back pain, depression.Assessment: failed fusion with residual left l5 s1 radiculopathies.On (b)(6) 2013: the patient presented with the following pre-op diagnosis: bilateral sacroiliac joint arthropathy.Lumbosacral pain.Left lower extremity radicular symptoms.Status post revision decompression and fusion at l5-s1.The patient underwent the following procedures: intravenous sedation.Fluoroscopy.Bilateral joint sacroiliac joint injections with steroid.No complications were reported.On (b)(6) 2013, the patient was diagnosed for low back pain and left radiculopathy.The patient underwent testing for evaluation to determine functional abilities and limitations, to determine ability to return to previous job and to determine physical abilities.On (b)(6) 2013, the patient presents today following bilateral si joint injections.The musculoskeletal reviews: leg pain, leg weakness, joint pain, joint swelling.Neurological review: balance problems, headaches and numbness.On (b)(6) 2013, (b)(6) 2012, (b)(6) 2011, the patient presented with back pain, foot pain, leg pain.The patient was diagnosed for status post lumbar spinal fusion, lumbar radiculopathy, chronic.Musculoskeletal review: joint aches, leg weakness, muscle weakness, muscle cramps.On (b)(6) 2013, the patient presented with back pain.The patient was diagnosed for lumbar pain with radiation down the left leg, myofascial pain, status post lumbar spinal fusion, and lumbar radiculopathy, chronic.Neurological exam: neurologic: normal coordination, negative romberg.Lumbar pain with radiation down left leg.Myofascial pain.Status post lumbar spinal fusion.Lumbar radiculopathy, chronic.On (b)(6) 2013: the patient presented with following pre-op diagnosis: 1.Bilateral sacroiliac joint arthropathy.Lumbosacral pain.Left lower extremity radicular symptoms.Status post revision decompression and fusion l5-s1.The patient underwent: intravenous sedation.C-arm fluoroscopy.Bilateral si joint injection with steroid.On (b)(6) 2013, as per medical records, the musculoskeletal review: positive for leg pain.On (b)(6) 2013: the patient presented for an office visit.Review of systems revealed back, leg (left) pain, balance problems.On (b)(6) 2013: the patient underwent lumbar myelogram with ct and 3d reconstructions due to left leg weakness, losing control of leg, bowel/bladder issues.Opinion: question shallow disc herniation at l4-5.Postoperative changes.Otherwise negative contrast plain film myelogram.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis with contrast due to left lower quadrant pain, nausea.Opinions: remote postoperative change.Otherwise negative contrast ct of the abdomen.Free fluid and a left corpus luteum cyst, status post hysterectomy.On (b)(6) 2014: the patient presented for chest pain follow up.Assessment: chest pain.Abnormal ecg.Cad in native artery.Hyperlipidemia.Hypertension, benign.On (b)(6) 2014: the patient presented with following pre-op diagnosis: bilateral si joint dysfunction.Lumbosacral pain.Chronic lle radicular symptoms and weakness.Status post decompression fusion with revision l5-s1.The patient continued to exhibit a chronic left l5 vs s1 radicular pattern with footdrop on the left.She subsequently developed symptoms on the right which radiated into the proximal thigh.The patient underwent, fluoroscopy, bilateral joint sacroiliac joint injections with steroid.No patient complications were reported.On (b)(6) 2014: the patient presented for follow up of back pain.Diagnosis: failed back syndrome.The patient had greater weakness of the left lower extremity.She had some pain at the left knee over the patella.There was clear swelling of the left knee compared to the right but no ecchymosis or temperature change.Assessment: secondary difficulties secondary to foot drop, involving the left knee.Neuropathic pain syndrome.On an unknown date in (b)(6) 2014, the patient underwent colonoscopy.On (b)(6) 2014: the patient presented with chronic lumbar hip and buttock pain.The patient was status post l5-s1 failed fusion.Preop diagnosis: bilateral sacroiliac joint dysfunction.Lumbar/hip/buttock pain.Chronic left lower extremity radicular symptoms with weakness.Status post decompression fusion with revision l5-s1.Procedures: iv sedation.Fluoroscopy.Bilateral sacroiliac joint injections with steroid.No complications reported.Impression: uncomplicated bilateral sacroiliac joint injections.On an unknown date in (b)(6) 2014, the patient underwent right breast lumpectomy.On (b)(6) 2014: the patient presented with following pre-op diagnoses: s/p decompression fusion with revision l5-s1.Chronic left lower extremity radicular symptoms and weakness.Lumbar/hip/buttock pain.Bilateral sacroiliac joint dysfunction.The patient underwent the following procedures: iv sedation.Fluoroscopy.Bilateral sacroiliac joint injections with steroid.No complication was reported.On (b)(6) 2014: the patient presented with knee pain.She was in a long-leg knee ankle foot orthosis.Exam of the left leg revealed diffuse atrophy.There was generalized weakness of the knee.She had tenderness to palpation along the lateral joint line of the patella tendon.Assessment: chronic left lumbar radiculopathy.Djd left knee.From an unknown date in (b)(6) 2014 till present, the patient has been diagnosed with heart attack and cardiology.Since the rhbmp-2/acs surgery, the patient has been having the following problems: extreme pain, pain more often than before rhbmp-2/acs surgery, bowel/bladder incontinence, localized edema, nerve injury, osteoarthritis, paralysis, pseudocysts, radiating leg pain, foot drop, additional surgery to help/correct with problems caused by rhbmp-2/acs, mental anguish/depression, lower left extremity weakness, and muscle spasms in lower back, gastrointestinal problems, bone growth, and non-union bone healing.She also had the following symptoms: numbness and tingling in left leg radiating down to feet; weakness in lower extremities making it difficult to walk or stand; constant lower back pain and muscle spasms; and a burning pain in left foot; constant ache in her left hip radiating down to the bottom of left foot; weakness in left ankle causing falls; bowel/bladder incontinence; mental anguish/depression; gastrointestinal issues.
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Event Description
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It was reported that on, (b)(6) 2013: the patient presented with the following pre-op diagnosis: bilateral sacroiliac joint arthropathy.Lumbosacral pain.Left lower extremity radicular symptoms.Status post revision decompression and fusion at l5-s1.The patient underwent the following procedures: intravenous sedation.Fluoroscopy.Bilateral joint sacroiliac joint injections with steroid.No complications were reported.On (b)(6) 2013: the patient presented for an office visit.Review of systems revealed back, leg (left) pain, balance problems.On (b)(6) 2014: patient presented with following diagnoses: failed back surgery syndrome with chronic residuals.On (b)(6) 2015: patient underwent x-ray of lumbosacral spine minimum 4 views including oblique and bending views.Impression: orthopedic hardware inferiorly.No acute process.No evidence of instability.On (b)(6) 2015: patient underwent x-ray of hip complete 2 or more views unilateral right.Impression: prior lumbosacral instrumentation and fusion.Right hip arthropathy with spurring.Differential may include femoral acetabular impingement.On (b)(6) 2015: patient underwent axial t2 x-ray and sagittal t2 x-ray.Impression: mild osteophytic changes in the left at l5-s1 may minimally contact the traversing left s1 nerve roots.No significant spinal canal stenosis at any level.Minimal inferior neural foraminal narrowing secondary to disc material at l3-4 and l4-5 without compromise of the exiting l3 on l4 nerve roots.
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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) 2014, patient presented for an office visit.On (b)(6) 2014, patient presented for an office visit due to thyroid flu.Assessment: ¿headache, thyroid.¿ on (b)(6) 2014, patient presented for an office visit for ct of the head with and without contrast thyroid ultrasound.Head ct findings: multi-slice axial tomographic images of the head were obtained prior to and during the administration of intravenous contrast.Thyroid us findings: the left lobe of the thyroid was 4.4 x 1.5 cm and the right lobe was 4.9 x1.7 cm.There was a 1 cm nodule in the mid-left thyroid with peripheral hypoechoic rim: this was generally a sign of a benign nodule and ultrasound follow-up was recommended.A 0.6 cm colloid cyst was present in the lower pole of the left thyroid.Although a history of hashimoto's thyroiditis was given, the parenchyma of the thyroid has a somewhat ¿homogeneous¿ thyroid echogenicity and not the typical appearance of hashimoto¿s thyroiditis.On (b)(6) 2014, patient presented for an office visit due to thyroid us head ct.Assessment: ¿thyroid.¿ on (b)(6) 2014, patient presented for an office visit due to thyroid us head ct.Assessment: headache, neck pain, dizziness, photosensitivity, nausea vomiting.Findings: sagittal, axial and coronal, images of the brain were acquired using multiple spin sequences, including post contrast sequences.On (b)(6) 2015, patient presented for office an office visit.On (b)(6) 2015, patient presented for office an office visit due to ¿dupena.¿ on (b)(6) 2015, patient presented for office an office visit due to flu and found new lump.On (b)(6) 2015, patient presented for an office due to benign breast tissue with no diagnostic pathologic abnormalities.He underwent ultrasound guided biopsy of the right breast.Conclusion: successful biopsy.Successful placement of a marker clip.On (b)(6) 2015, patient presented for an office visit.Assessment: ¿hyperized.¿ on (b)(6) 2015, patient presented for office an office visit due to flu, frustrated.On (b)(6) 2015, patient presented due to the chief complaint of heart problems.On (b)(6) 2015, patient presented due to the chief complaint of heart problems.Assessment: cellulitis.On (b)(6) 2015, patient presented due to the chief complaints of arm pain, swollen, pain up into shoulder.Assessment: ¿cellulitis, necrolr apea.¿ on (b)(6) 2013, the patient was diagnosed for low back pain and left radiculopathy.The patient underwent testing for evaluation to determine functional abilities and limitations, to determine ability to return to previous job and to determine physical abilities.On (b)(6) 2015 , the patient underwent physical therapy due to lumbago and pain in limb.On (b)(6) 2015, the patient presented for physical therapy due to low back pain and left leg pain.
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Event Description
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It was reported that on (b)(6) 2015: patient underwent x-ray myelography of lumbosacral spine.Impression: anterior posterior surgical changes at l5-s1.Mild osteophytic changes arising posteriorly from the left aspect at the l5-s1 level may minimally contact and displace the traversing left s1 nerve root; there were spondylitic changes without significant spinal stenosis at any level.Mild left neural foraminal narrowing was seen at l3-4.On (b)(6) 2015: patient underwent mri of lumbar spine without contrast.Impression: mild osteophytic changes in the left at l5-s1 may minimally contact the traversing left s1 nerve roots.No significant spinal canal stenosis at any level.Minimal inferior neural foraminal narrowing secondary to disc material at l3-4 and l4-5 without compromise of the exiting l3 to l4 nerve root.
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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) 2013: patient presented for follow-up.Impression: residual left s1 radiculopathy, response to direct nerve block.On (b)(6) 2015: patient underwent x-ray myelography of lumbosacral spine.Impression: anterior posterior surgical changes at l5-s1.Mild osteophytic changes arising posteriorly from the left aspect at the l5-s1 level may minimally contact and displace the traversing left s1 nerve root.There were spondylitic changes without significant spinal stenosis at any level.Mild left neural foraminal narrowing is seen at l3-4.On (b)(6) 2015: patient underwent mri of lumbar spine without contrast.Impression: mild osteophytic changes in the left at l5-s1 may minimally contact the traversing left s1 nerve roots.No significant spinal canal stenosis at any level.Minimal inferior neural foraminal narrowing secondary to disc material at l3-4 and l4-5 without compromise of the exiting l3 to l4 nerve root.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records it was reported that on (b)(6) 2002, patient presented with problems in right heel.Patient reported pain in volar aspect of her right foot.On (b)(6) 2003: the patient presented for a doctor visit.The reason for visit was chest pain.On (b)(6) 2003: the patient presented for an office visit and underwent "egd" procedure.Impressions: medium hiatal hernia.Chronic gastritis.On (b)(6) 2003: the patient presented for an office visit with an admitting diagnosis of stress and urinary continence.The patient underwent x-rays of the upper "gi".Impression: negative upper gi except for a small hiatal hernia.On (b)(6) 2003: the patient presented for an office visit and was admitted with a diagnosis of cough.The patient also underwent x rays of the chest.Opinion: negative chest.On (b)(6) 2003: the patient presented for an office visit with a bladder infection.On (b)(6) 2004: the patient presented for an office visit with a clinical history of vomiting and underwent x-rays for "upper gi with kub".Opinion: narrowing of the anastomosis b/w the gastric remnant and jejunum.On (b)(6) 2004: the patient underwent x-rays of the abdomen due to abdominal pain.Opinion: no extravasation of anastomotic stricture g astric pouch/jejunum.On (b)(6) 2004, (b)(6) 2005, (b)(6) 2006, (b)(6) 2008: the patient presented for an office visit.The patient underwent "egd" procedure.Impression: the esophagus appeared normal.The gastroesophageal junction appeared normal.Evidence of gastroplasty in the stomach.The duodenum appeared normal.Dyspepsia.On (b)(6) 2004: the patient got admitted with the admitting diagnosis of vomiting.On (b)(6) 2003, (b)(6) 2004, (b)(6) 2005: the patient presented for an office visit.On (b)(6) 2004: the patient presented for an office visit due to pre-term labor.On (b)(6) 2004: the patient presented for an office visit due to "rh" disease of pregnancy and underwent "ob" ultrasound (limited).Opinion: normal middle cerebral artery peak systolic velocity for fetal age.On (b)(6) 2005: the patient presented for an office visit due to side pain.On (b)(6) 2005: the patient presented for right sided abdominal pain and underwent ultrasound of the abdomen.Opinion: normal abdominal ultrasound; negative pelvic ultrasound.On (b)(6) 2006: the patient presented for an office visit and the reason for the visit was "thyroid nodules".The patient underwent ultrasound of the thyroid.Opinion: mild inhomogeneity of the thyroid, consistent with hashimoto's thyroiditis.No discrete nodules or masses identified.On (b)(6) 2006: the patient presented for an office visit due to bilateral hip pain.Assessment of patient's examination: lumbago.On (b)(6) 2006: the patient presented for an office visit due to abdominal pain.The patient underwent abdominal ultrasound.Opinion: negative abdomen ultrasound.On (b)(6) 2007: the patient presented for an office visit due to "tsh".The patient was diagnosed with hypoth yroidism.On (b)(6) 2008: the patient presented for an office visit due to left abdominal side pain.The patient underwent "upper gi w kub".Impression: suspect ulcer in the distal esophagus.Post anastomotic diverticulum.Spontaneous reflux to the level of carina.On (b)(6) 2008: the patient presented for an office visit due to abdominal pain and underwent ct scan of the abdomen.Finding: herniation of the small bowel brought up to anastomose with the gastric pouch through the hiatal hernia into the lower mediastinum, along with proximal gastric pouch.There is no evidence of visible ulceration.Linear foci of contrast represent infolding of gastric mucosa.The patient also underwent ct scan of the abdominal pelvis with contrast.Impression: hiatal hernia with several small ulcerations, one of which extends to the serosal surface.On (b)(6) 2008: the patient presented for an office visit due to abdominal pain and underwent hepatobiliary imaging and gbef.Impression: normal liver parenchymal function, normal visualization of the common bile duct and gallbladder, and normal emptying into the duodenum.Very high ejection fraction of 91% after kinevac injection.On (b)(6) 2008 the patient was presented for office visit with epigastric pain.Assessments: epigastric pain and biliary dyskinesia.On (b)(6) 2008: the patient underwent "laparoscopic cholecystectomy" with the pre-operative diagnosis of biliary dyskinesia and colic.Findings: non-inflamed gallbladder.Normal-appearing extrahepatic biliary tree.Final pathologic diagnosis of the gallbladder: chronic cholecystitis.On (b)(6) 2008, (b)(6) 2009: the patient presented with "iron def anemia".On (b)(6) 2008, patient underwent x-ray of ankle which showed no fractures or malalignment of bony structures.There was soft tissue swelling overlying lateral and medial malleolus.No evidence of acute body trauma.On (b)(6) 2008, patient presented with complaint of tenderness in right ankle.X-ray showed no evidence of fracture or other abnormality.On (b)(6) 2008, (b)(6) 2009: the patient presented for an office visit reporting right ankle sprain.On (b)(6) 2008, (b)(6) 2009, patient presented with complaint of tenderness in right ankle.On (b)(6) 2011, patient presented for physical therapy and reported back pain.On (b)(6) 2011, patient presented for physical therapy and reported low back and left leg pain.On (b)(6) 2012: the patient was admitted with excessive or frequent menstruation.Final pathologic diagnosis: endometrium, biopsy; prol iferative endometrium.On (b)(6) 2014: the patient was diagnosed with abdominal pain, malaise and fatigue.On (b)(6) 2014: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent bilateral mammograms.Impression: area of increased density where the patient has a palpable abnormality.Category 4 classification, biopsy recommended.On (b)(6) 2014 the patient was presented for office visit with right breast mass.Assessment: birads 4 right breast mass in woman on chronic pain medication for lumbar spine problems.On (b)(6) 2014: the patient underwent open excisional right breast biopsy due to right breast mass.Findings: firm, multinodular breast tissue in the area of palpable concern.The total excised volume of breast tissue containing several small nodules was 3 cm x 4 cm x 2 cm.On (b)(6) 2014: the patient presented for an office visit and was diagnosed with cystic mastopathy.Final pathologic diagnosis: right breast, lesion of lateral aspect mastectomy with separate inferior and lateral margins, fibrocystic changes.Changes suggestive of pseudoangiomatous stromal hyperplasia.Negative for atypism, hyperplasia or malignancy.On (b)(6) 2015: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent diagnostic right mammogram for breast lump and limited right breast ultrasound.Impression: right breast nodule increased architectural distortion.Ultrasound guided biopsy is again recommended.Bi-rads category 4.On (b)(6) 2015: the patient presented for an office visit and was diagnosed with lump or mass in breast.The patient underwent digital diagnostic mammogram of the right breast and core biopsy of the right breast.Conclusions: successful biopsy.Successful placement of a marker clip.On (b)(6) 2015: the patient presented with host of problems like abnormal cardiovascular system function, chest pain, esophageal reflux, old myocardial infarction, unspecified essential hypertension, irritable bowel syndrome and encounter for long-term use of aspirin.The patient underwent the following procedures: left heart catheterization.Selective left and right coronary angiography.Left ventriculography (b)(6) 2015: the patient presented for an office visit for a second opinion and to establish cardiovascular care.Assessment: chest pain.Palpitations.Esential hypertension.Hyperlipidemia.
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Event Description
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It was reported that on, (b)(6) 2011: the patient presented for postoperative follow up.On (b)(6) 2011: the patient presented for a postoperative visit.On (b)(6) 2012 patient presented for office visit with consistent pain radiating to l buttock, posterior thigh, lateral leg and lateral aspect of the l foot.Impressions: the results of the electromyography and nerve conduction studies of the left lower extremity were felt to be consistent with the presence of an electro physiologically-moderate acute and chronic left si radiculopathy.The nerve conduction and electromyography studies of the right rower extremity were normal, there was no evidence of entrapment or other peripheral neuropathy, lumbosacral plexopathy, lumbar radiculopathy or myopathy.On (b)(6) 2012 patient presented for office visit with following procedure left s1 tfesi.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented for office visit with complaint of intense numbness that wraps around the left hip to groin and all the way down to left foot.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented for follow-up visit with complaint of chronic pain in the low back, as well as pain in the l hip, lateral thigh and leg and lateral foot.Impressions: consistent with the presence of an electro physiologically-moderate, primarily chronic, si radiculopathy.Changes classically associated with acute injury remain, which may be the case for quite some time (a year being not all that unusual) following an acute injury, with or without surgery.Again, no conclusive evidence of root injury, acute or chronic, could be demonstrated.Basically, there has been little interval change since (b)(6) of this year.The nerve conduction and electromyography studies of the right lower extremity were again normal; there was no evidence of entrapment or other peripheral neuropathy, lumbosacral plexopathy, lumbar radiculopathy or myopathy - on the right side.On (b)(6) 2012 patient underwent following procedure: bilateral si joint injection.On (b)(6) 2013 patient underwent following procedure: bilateral si joint injection.On (b)(6) 2013: the patient presented with following pre-op diagnosis: bilateral sacroiliac joint arthropathy.Lumbosacral pain.Left lower extremity radicular symptoms.Status post revision decompression and fusion l5-s1.The patient underwent: intravenous sedation.C-arm fluoroscopy.Bilateral si joint injection with steroid.On (b)(6) 2013 patient presented for office visit.On (b)(6) 2013: patient presented for followup, continuing with her pain management program in (b)(6).Patient's review of systems revealed: gastrointestinal: present- indigestion.Musculoskeletal: present- back pain, back stiffness and leg weakness.Neurological: present- balance problems.On (b)(6) 2013: patient presented with complaints of chronic lumbar radiculopathy.On (b)(6) 2013: patient was diagnosed pre-operatively with: bilateral sacroiliac joint arthropathy.Lumbosacral pain.Chronic left lower extremity radicular symptoms.Status post decompression/fusion with revision l5-s1.Patient underwent the following procedures: intravenous sedation.Fluoroscopy.Bilateral sacroiliac joint injections with steroid on (b)(6) 2014: patient presented for evaluation and discussion of lle kafo.Patient stated that her knee had been giving out and buckling.On (b)(6) 2014, : patient presented for office visit.On (b)(6) 2014 the patient was presented for office visit with back pain, pain in arms, legs and joints, constipation, nausea and difficulty in sleeping.On (b)(6) 2014: the patient underwent x-rays of the knee due to left knee pain and buckling.Impression: bad left knee with advanced changes in the retropatellar region and early to moderate changes of the lateral joint line.On (b)(6) 2015, the patient presented for office visit due to complaint of pain in joint , pelvic region , thigh.On (b)(6) 2015: patient presented with complaint for si joint pain.Patient had persistent left lower extremity pain and weakness.Impression: uncomplicated repeat bilateral sacroiliac joint injections.Planned lateral branch rhizotomy in the near future.On (b)(6) 2015: patient presented for office visit.Patient underwent ct of lumbar spine.Impression: anterior posterior surgical changes at l5-s1.Mild osteophytic changes arising posteriorly from the left aspect at the l5-s1 level may minimally contact and displace the traversing left s1 nerve root.There are spondylitic changes without significant spinal stenosis at any level.Mild left neural foraminal narrowing is seen at l3-4.On (b)(6) 2015: patient presented with chief complaint of left lower extremity pain.Patient underwent an intra-articular hip injection.On (b)(6) 2015: patient presented for follow up on left lower extremity symptoms, and on referral for a left l3-4 transforaminal epidural steroid injection.Patient was diagnosed pre-operatively with status post l5-s1 fusion, left lower extremity weakness, bilateral hip pain, chronic sacroilitis.Patient underwent fluoroscopic study and left l3-4 transforaminal epidural steroid injection.Impression: uncomplicated l3-4 transforaminal epidural steroid injection on the left.On (b)(6) 2015: patient got admitted with admitting diagnosis: lumbago and other musculooskeletal symptoms referable to limbs, pain in joint, pelvic region and thigh, sacroilitis.On (b)(6) 2015, (b)(6) 2016: patient underwent right hip therapeutic injection under fluoroscopic guidance.On (b)(6) 2015: patient visited for follow up on left lower extremity symptoms and complained of back pain.A 10 point review of systems completed and found to be otherwise negative.Assessment: left lower extremity weakness, right hip pain, bilateral sacro-iliac joint pain.On (b)(6) 2015: patient presented for an office visit and stated that she had left quad atrophy over the last year with weakness and pain in the posterior aspect of the leg as well.On (b)(6) 2015: the patient was administered steroid injection to the right hip under fluoroscopic guidance, due to right hip pain.On (b)(6) 2015: patient presented to er for wound repair.On (b)(6) 2015: patient presented with complaint of right knee pain.Assessment: osteoarthritis right knee, effusion right knee.Patient underwent x-ray of right knee (3 view).Impression: early osteoarthritic changes evidenced by some lateral joint space narrowing and spiking of the tibial spines.There is also a medial osteochondroma of the distal femur.On (b)(6) 2016 the patient was administered steroid injection to the right hip due to right hip pain that radiated into the groin and down the leg.On (b)(6) 2016: patient visited for follow up on right hip.
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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) 2013: the patient called doctor and decided to have si joint injection on (b)(6) 2013.Patient presented with complaints of trouble in breathing.On (b)(6) 2015: patient presented with complaint for si joint pain.Patient had persistent left lower extremity pain and weakness.Impression: uncomplicated repeat bilateral sacroiliac joint injections.Planned lateral branch rhizotomy in the near future.The patient underwent si joint injections.On (b)(6) 2015: patient got admitted with admitting diagnosis: lumbago and other musculoskeletal symptoms referable to limbs, pain in joint, pelvic region and thigh, sacroilitis.The patient had l3 injection on lt side (b)(6) 2015 patient presented due to the chief complaint of heart problems.The patient had si joint rf ablation on right side.Nine spots of each side were burned.On (b)(6) 2015 the patient had right hip and left si joint rf ablation injection.On (b)(6) 2016: the patient reported via social media that she had pain, ruptured and fragmented so the disc material and fragments oozed out the spinal canal.On (b)(6) 2016: the patient underwent cta coronary angiogram on an unknown date: the patient underwent x rays of her rt knee, aspirated about an ounce of serous fluid off of it, steroid injected and brace was fitted.On (b)(6) 2014 patient presented for an office visit.On (b)(6) 2014: the patient presented for esophagogastroduodenoscopy.Impressions: normal esophagus, anastomosis visualized near the stomach.Minimal pouch present, healthy anastamosis.Normal duodenum.The patient presented for colonoscopy.Impressions: mild diverticulosis found in the sigmoid colon.No large masses or lesions seen, colon was redundant, scope only passed to hepatic flexure.On (b)(6) 2016: the patient presented for x-ray due to right hip pain.Impressions: osteoarthritic changes right hip.On (b)(6) 2016 the patient was presented or office visit with burning with urination, urinary frequency, bladder spasm and abdominal pain.Assessments: urinary tract infection.
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Manufacturer Narrative
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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) 2015: the patient presented with slow ongoing re-epithelialization of right wrist wound.The patient had a bit of bleeding.The scab appears to have cracked but there was no cellulitis or evidence of infection or chronic granuloma.On (b)(6) 2016: the patient presented for follow up visit for right hip pain.
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Event Description
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It was reported that on, (b)(6) 2015: the patient presented with weakness in left lower extremity.Assessment: left lower extremity radiculopathy and chronic footdrop.On (b)(6) 2015: the patient presented with left leg weakness and spasticity, right hip pain.Assessment: left lower extremity radiculop athy and spasticity, right hip degeneration.
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Manufacturer Narrative
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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) 2014 patient presented for office visit.On (b)(6) 2014 patient presented for office visit.On (b)(6) 2014 patient underwent ecg examination.Abnormal ecg.On (b)(6) 2014 patient underwent following procedure: stress procedure.On (b)(6) 2015 patient presented for office an office visit due to flu, frustrated.Patient presented for follow-up of palpitations and chest pain.Patient underwent ecg examination.Abnormal ecg.On (b)(6) 2015, patient presented for office visit.On (b)(6) 2015 patient presented for office visit.Assessment: depression.On (b)(6) 2016 patient presented for office visit with multiple health concerns.She complaints of an increase in an increase in hot flashes.Assessment: depression/anxiety, hot flashes, hypothyroidism, hyperlipidemia, vitamin d deficiency, vitamin b12 deficiency.(b)(6) 2016 patient presented for office visit for physical examination.Assessment: depression/anxiety, hot flashes, hypothyroidism, hyperlipidemia, vitamin d deficiency, vitamin b12 deficiency.
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Manufacturer Narrative
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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 reprorted that on, (b)(6) 2014 patient underwent ¿ct angiography coronary arteries w cntrs¿.Conclusion: widely patent coronary arterial tree without any evidence of coronary atherosclerosis or plaquing.The patient has a right dominant coronary system.On (b)(6) 2016: the patient presented for an office visit with left-sided sacroiliac joint radio-frequency ablation.
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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) 2016 : examination: neurological: reports numbness in both lower legs and feet.Musculoskeletal: reports chronic back pain.Reports joint and muscle weakness in both legs with left>right.Reports pain in both legs again left >right here is decreased range of motion in the lumbar spine.On (b)(6) 2016 :lower extremity neuro exam: muscle strength is 4/5 in all major lower extremity muscle groups.Deep tendon reflexes are absent in the patellar and achilles distributions bilaterally.Sensation is normal to deep touch in all distributions but she does complain of numbness in the medial surface of the lower legs from knee to toes.Gait: abnormal normal.Unsteady.Unable to perform tandem gait safely.On (b)(6) 2016: patient presented with complaint of left foot drop, chronic radiculopathy, and right hip pain.Patient underwent x-ray due to right hip degenerative joint disease.Impression: right hip injection under fluoroscopic guidance.On (b)(6) 2016: the patient presented for an office visit regarding right knee.On (b)(6) 2016: the patient presented for repeated right sacroiliac joint radiofrequency ablation.Pre-op diagnosis: status post lumbar decompression/fusion with revision.Neurotmesis.Sacroiliac joint dysfunction.The patient underwent the following procedures: iv sedation.Fluoroscopy.Repeat right joint radio frequency ablation.No patient complications were reported.
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Manufacturer Narrative
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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) 2015 , the patient presented for office visit.The patient reported recurrent chest pains and weakness in the left leg.Impression: coronary artery disease; hyperlipidemia; chest pain; benign hypertension.
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