| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Syncope (1610); Arteriosclerosis (1722); Pulmonary Emphysema (1832); Fall (1848); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Osteopenia/ Osteoporosis (2651); No Code Available (3191)
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| Event Date 11/07/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment for follow-up dated 28-nov-2018.The follow up information does not change the prior assessment of the case.This case concerns a patient who experienced syncope while on therapy synvisc one.With based on the available information, pharmacological plausibility can be established between the event and suspect product.However, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.
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Event Description
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Unconscious/ syncope/ syncopal episode/ passed out/ collapsed [syncope] ; slightly elevated glucose of 126 [blood glucose increased] ; oid lacunar infarct in the anterior right external capsule [lacunar infarction] ([ct scan abnormal]); relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing [postural hypotension] ; auto neutrophils absolute # high [absolute neutrophil count increased] ; auto lymphocytes % low [lymphocyte percentage decreased] ; background osteopenia [osteopenia] ; confused temporarily upon awakening [confused] ; vomiting [vomiting] ; nausea [nausea] ; diastolic blood pressure abnormal [blood pressure diastolic abnormal] ; eyes hurt when he moves them/ eye sockets sore [painful eye movement] ; background emphysema [emphysema] ; coronary and aortic valvular atherosclerosis [arteriosclerosis] ; sweating [sweating] ; weakness [weakness] ; lightheaded and near syncopal [lightheadedness] ; knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well [therapeutic response decreased] ([eye pain], [unable to walk]) stiffness [stiffness] ; fall [fall] ; weight bearing activities [weight bearing difficulty] ; pain with weightbearing activities standing and twisting [pain upon movement] ; decreased range of motion [joint range of motion decreased] ; tenderness [tenderness] ; crepitus [joint crepitation]; small abrasion [abrasion] ; right knee is twice the size of the left and is warm and red [swelling of r knee] ; joint pain [joint pain].Case narrative: this case is cross referenced with case (b)(4) (same patient).Based on the information received on (b)(6) 2018, name of company suspect product updated to synvisc-one from synvisc.Initial information received on (b)(6) 2018 from united states regarding an unsolicited valid serious case received from a patient.This case involves a (b)(6) male patient who experienced unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsule, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema, sweating, weakness, lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, confused temporarily upon awakening, nausea, vomiting, coronary and aortic valvular atherosclerosis, diastolic blood pressure abnormal, stiffness, eye hurt when he moves them/ eye sock sore, fall, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain (unknown: latency), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included caffeine allergy, drug hypersensitivity, wrist surgery, cataract, head injury, fracture, post-traumatic stress disorder, nasal septum deviation, swelling, pain in extremity, peripheral sensory neuropathy, sciatica, glossitis, onychomycosis, obese, colonoscopy normal ,rhinitis allergic and dry eye.The patient's past medical treatment included synvisc.The patient's family history included cerebrovascular accident with mother and cardiac disorder with brother and sister.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing arthralgia, atrial fibrillation, osteoarthritis diffusely, right knee most symptomatic lately/ djd, gastrooesophageal reflux disease, osteoarthritis, hypercholesterolaemia, hypothyroidism, osteoarthritis and ex-tobacco user with former smoker, cigarettes, 40 year(s).Previous treatment: self initiated treatment.Concomitant medications included omeprazole (protonix [omeprazole]) for gastrooesophageal reflux disease; famotidine (pepcid [famotidine]) for gastrooesophageal reflux disease; levofloxacin hemihydrate (levonox); oxycodone hydrochloride, paracetamol (acetaminophen w/oxycodone) for pain; levothyroxine (levothyroxine); pantoprazole (pantoprazole); ranitidine hydrochloride (ranitidine); fentanyl (fentanyl); calcium chloride, potassium chloride, sodium lactate (lactated ringers); ondansetron (zofran [ondansetron]); meloxicam (meloxicam) for pain and inflammation; fluticasone propionate (fluticasone propionate); carboxymethylcellulose (carboxymethylcellulose); and citalopram hydrobromide (citalopram eg [citalopram hydrobromide]).On (b)(6) 2017, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), injection, via intra- articular route for unilateral primary osteoarthritis of right knee.Right knee was prepped with betadine and ethyl chloride.Synvisc one injection was injected.Patient tolerated the procedure well and was discharged with stable vitals.On (b)(6) 2017, 1 day after synvisc injection, the patient developed an event of a serious unconscious/ syncope/ syncopal episode/ passed out (syncope) 1 day after starting use of hylan g-f 20 and sodium hyaluronate.The patient was hospitalized on the same day this event occurred.The patient sat up and got lightheaded and near syncopal and so he laid back down.Later, the patient did go ahead and get up out of bed and had made it to the kitchen and was sitting down when the patient suddenly went unconscious and collapsed to the floor.It was reported that he felt confused temporarily upon awakening (confusional state).The patient had one episode of nausea and vomiting en route to the hospital on (b)(6) 2018.On admission the patient was diagnosed with weakness, sweating, unconscious/ syncope/ syncopal episode/ passed out and his vitals were normal.Comprehensive metabolic profile was universally normal except slightly elevated glucose of 126.The ct did show an oid lacunar infarct in the anterior right external capsule, orthostatic vital signs did demonstrate a significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing.During hospitalization his auto lymphocytes % low (lymphocyte percentage decreased), serious auto neutrophils absolute # high (neutrophil count increased) and ct angiogram of the chest with reformatting showed the background osteopenia (osteopenia), mild to moderate degree of background emphysema, chronic appearing compression deformities of t5, t6, t9, t12, and l1 , exaggerated upper thoracic kyphosis.The patient had knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well (therapeutic response decreased) with symptoms of r knee swelling and r knee pain with ambulation/ antalgic gait/ decreased cadence/ step-to pattern and denied headache or neck discomfort.He doesn't take aspirin daily.He states he doesn't have diabetes or hypertension and was alert and oriented x3 and in no acute distress.On reexamination, patient had normal cbc and chemistry profile.Patient remains neurologically intact.Head ct showed some mild small vessel disease and an old lacunar infarct.Attempted to do orthostatic vital signs but with difficulty.The patient was discharged on (b)(6) 2017.On unknown date, patient experienced fall and was having pain.He was also having pain with weightbearing activities standing and twisting.Patient also experienced from joint pain and decreased range of motion.He also showed mild crepitus and mild tenderness.A small abrasion was also observed on his body.Relevant laboratory test results included: activated partial thromboplastin time - on (b)(6) 2017: 27.3 [11:18 est]; albumin globulin ratio (1.1 - 1.6 unk) - on (b)(6) 2017: 1.0 unk [low]; blood glucose increased (70 - 105 mg/dl) - on (b)(6) 2017: 126 mg/dl [time - 11:18]; on an unknown date: 126 mg/dl [high]; blood pressure diastolic - on (b)(6) 2017: 101 unk [abnormal]; blood pressure measurement - on (b)(6) 2017: 133/67 mmhg [time- 12:42 est]; on an unknown date: 135/56 mmhg; blood urea decreased (12 - 20 unk) - on (b)(6) 2017: 11 unk; body temperature - on an unknown date: 98 f; electrocardiogram - on (b)(6) 2017: [a.Fib, rate 83]; heart rate - on (b)(6) 2017: 81 unk [bpm; time- 12:42 est]; on an unknown date: 86 unk [units- bpm]; international normalised ratio - on (b)(6) 2017: 1.0 [anticoagulation monitoring]; lymphocyte percentage - on (b)(6) 2017: 17.6 % [low]; mean arterial pressure - on (b)(6) 2017: 89 mmhg [time- 12:42 est]; neutrophil count - on (b)(6) 2017: 7.8 unk [units- 10*3/mcl.Time- 11:18 est]: oxygen saturation - on (b)(6) 2017: 97 % [time- 12:42 est]; respiratory rate - on (b)(6) 2017: 18 unk [br/min; time- 12:42 est]; on an unknown date: 16 unk [br/min].Final diagnosis was stiffness, vomiting, nausea, confused temporarily upon awakening, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, lightheaded and near syncopal, weakness, sweating, auto lymphocytes % low, auto neutrophils absolute # high, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, oid lacunar infarct in the anterior right external capsule, slightly elevated glucose of 126, unconscious/ syncope/ syncopal episode/ passed out, diastolic blood pressure abnormal, eyes hurt when he moves them/ eye sore, coronary and aortic valvular atherosclerosis, background emphysema and background osteopenia.An unknown corrective treatment was received.The patient outcome is reported as unknown for lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain, as recovered / resolved on an unknown date for unconscious/ syncope/ syncopal episode/ passed out, as unknown for confused temporarily upon awakening slightly elevated glucose of 126, auto neutrophils absolute # high, oid lacunar infarct in the anterior right external capsule, ct head abnormal, stiffness as recovered / resolved on (b)(6) 017 for relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing,diastolic blood pressure abnormal, auto lymphocytes % low,ambulation/ antalgic gait/ decreased cadence/ step-to pattern, vomiting, nausea, background emphysema, background osteopenia, as for coronary and aortic valvular atherosclerosis, r knee swelling, r knee pain, eyes hurt when he moves them/ eye socket sore, weakness, sweating.Ptc investigation was initiated and results are pending for the same.Seriousness criteria- hospitalization for unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsule, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 112 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema.Additional information received on (b)(6) 2018 from healthcare professional.Event of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain were added.Name of suspect product updated to synvisc one from synvisc.Clinical course updated.Text amended accordingly.Follow up information was received on 25-sep-2018.No new information was received.Additional information received on (b)(6) 2018 from healthcare professional.Medical history was added.Indication of the suspect product was updated.Clinical course updated and text amended accordingly.
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Event Description
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Unconscious/ syncope/ syncopal episode/ passed out/ collapsed [syncope].Slightly elevated glucose of 126 [blood glucose increased].Oid lacunar infarct in the anterior right external capsuie [lacunar infarction] ([ct scan abnormal]).Relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing [postural hypotension].Auto neutrophils absolute # high [absolute neutrophil count increased].Auto lymphocytes % low [lymphocyte percentage decreased].Background osteopenia [osteopenia].Background emphysema [emphysema].Sweating [sweating].Weakness [weakness].Confused temporarily upon awakening [confused].Vomiting [vomiting].Nausea [nausea].Diastolic blood pressure abnormal [blood pressure diastolic abnormal].Eyes hurt when he moves them/ eye sockets sore [painful eye movement].Coronary and aortic valvular atherosclerosis [arteriosclerosis].Lightheaded and near syncopal [lightheadedness].Knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well [therapeutic response decreased] ([eye pain], [unable to walk]).Stiffness [stiffness].Fall [fall].Weight bearing activities [weight bearing difficulty].Pain with weightbearing activities standing and twisting [pain upon movement].Decreased range of motion [joint range of motion decreased].Tenderness [tenderness].Crepitus [joint crepitation].Small abrasion [abrasion].Right knee is twice the size of the left and is warm and red [swelling of r knee].Joint pain [joint pain].Case narrative: this case is cross referenced with case: (b)(4) (same patient).Based on the information received on 13-sep-2018, name of company suspect product updated to synvisc-one from synvisc.Initial information received on 13-sep-2018 from united states regarding an unsolicited valid serious case received from a patient.This case involves a 73 years old male patient who experienced unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsule, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema, sweating, weakness, lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, confused temporarily upon awakening, nausea, vomiting, coronary and aortic valvular atherosclerosis, diastolic blood pressure abnormal, stiffness, eye hurt when he moves them/ eye sock sore, fall, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain (unknown: latency), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included caffeine allergy, drug hypersensitivity, wrist surgery, cataract, head injury, fracture, post-traumatic stress disorder, nasal septum deviation, swelling, pain in extremity, peripheral sensory neuropathy, sciatica, glossitis, onychomycosis, obese, colonoscopy normal ,rhinitis allergic and dry eye.The patient's past medical treatment included synvisc.The patient's family history included cerebrovascular accident with mother and cardiac disorder with brother and sister.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing arthralgia, atrial fibrillation, osteoarthritis diffusely, right knee most symptomatic lately/ djd, gastrooesophageal reflux disease, osteoarthritis, hypercholesterolaemia, hypothyroidism, osteoarthritis and ex-tobacco user with former smoker, cigarettes, 40 year(s).Previous treatment: self initiated treatment.Concomitant medications included omeprazole (protonix [omeprazole]) for gastrooesophageal reflux disease; famotidine (pepcid [famotidine]) for gastrooesophageal reflux disease; levofloxacin hemihydrate (levonox); oxycodone hydrochloride, paracetamol (acetaminophen w/oxycodone) for pain; levothyroxine (levothyroxine); pantoprazole (pantoprazole); ranitidine hydrochloride (rantidine); fentanyl (fentanyl); calcium chloride, potassium chloride, sodium lactate (lactated ringers); ondansetron (zofran [ondansetron]); meloxicam (meloxicam) for pain and inflammation; fluticasone propionate (fluticasone propionate); carboxymethylcellulose (carboxymethylcellulose); and citalopram hydrobromide (citalopram eg [citalopram hydrobromide]).On (b)(6) 2017, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), injection, via intra- articular route for unilateral primary osteoarthritis of right knee.Right knee was prepped with betadine and ethyl chloride.Synvisc one injection was injected.Patient tolerated the procedure well and was discharged with stable vitals.On (b)(6) 2017, 1 day after synvisc injection, the patient developed an event of a serious unconscious/ syncope/ syncopal episode/ passed out (syncope) 1 day after starting use of hylan g-f 20 and sodium hyaluronate.The patient was hospitalized on the same day this event occurred.The patient sat up and got lightheaded and near syncopal and so he laid back down.Later, the patient did go ahead and get up out of bed and had made it to the kitchen and was sitting down when the patient suddenly went unconscious and collapsed to the floor.It was reported that he felt confused temporarily upon awakening (confusional state).The patient had one episode of nausea and vomiting en route to the hospital on (b)(6) 2018.On admission the patient was diagnosed with weakness, sweating, unconscious/ syncope/ syncopal episode/ passed out and his vitals were normal.Comprehensive metabolic profile was universally normal except slightly elevated glucose of 126.The ct did show an oid lacunar infarct in the anterior right external capsule, orthostatic vital signs did demonstrate a significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing.During hospitalization his auto lymphocytes % low (lymphocyte percentage decreased), serious auto neutrophils absolute # high (neutrophil count increased) and ct angiogram of the chest with reformatting showed the background osteopenia (osteopenia), mild to moderate degree of background emphysema, chronic appearing compression deformities of t5, t6, t9, t12, and l1 , exaggerated upper thoracic kyphosis.The patient had knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well (therapeutic response decreased) with symptoms of r knee swelling and r knee pain with ambulation/ antalgic gait/ decreased cadence/ step-to pattern and denied headache or neck discomfort.He doesn't take aspirin daily.He states he doesn't have diabetes or hypertension and was alert and oriented x3 and in no acute distress.On reexamination, patient had normal cbc and chemistry profile.Patient remains neurologically intact.Head ct showed some mild small vessel disease and an old lacunar infarct.Attempted to do orthostatic vital signs but with difficulty.The patient was discharged on (b)(6) 2017.On unknown date, patient experienced fall and was having pain.He was also having pain with weightbearing activities standing and twisting.Patient also experienced from joint pain and decreased range of motion.He also showed mild crepitus and mild tenderness.A small abrasion was also observed on his body.Relevant laboratory test results included: activated partial thromboplastin time - on (b)(6) 2017: 27.3 [11:18 est].Albumin globulin ratio (1.1 - 1.6 unk) - on (b)(6) 2017: 1.0 unk [low].Blood glucose increased (70 - 105 mg/dl) - on (b)(6) 2017: 126 mg/dl [time - 11:18]; on an unknown date: 126 mg/dl [high].Blood pressure diastolic - on (b)(6) 2017: 101 unk [abnormal].Blood pressure measurement - on (b)(6) 2017: 133/67 mmhg [time- 12:42 est]; on an unknown date: 135/56 mmhg.Blood urea decreased (12 - 20 unk) - on (b)(6) 2017: 11 unk.Body temperature - on an unknown date: 98 f.Electrocardiogram - on (b)(6) 2017: [a.Fib, rate 83].Heart rate - on (b)(6) 2017: 81 unk [bpm.Time- 12:42 est]; on an unknown date: 86 unk [units- bpm].International normalised ratio - on (b)(6) 2017: 1.0 [anticoagulation monitoring].Lymphocyte percentage - on (b)(6) 2017: 17.6 % [low].Mean arterial pressure - on (b)(6) 2017: 89 mmhg [time- 12:42 est].Neutrophil count - on (b)(6) 2017: 7.8 unk [units- 10*3/mcl.Time- 11:18 est].Oxygen saturation - on (b)(6) 2017: 97 % [time- 12:42 est].Respiratory rate - on (b)(6) 2017: 18 unk [br/min.Time- 12:42 est]; on an unknown date: 16 unk [br/min].Final diagnosis was stiffness, vomiting, nausea, confused temporarily upon awakening, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, lightheaded and near syncopal, weakness, sweating, auto lymphocytes % low, auto neutrophils absolute # high, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, oid lacunar infarct in the anterior right external capsule, slightly elevated glucose of 126, unconscious/ syncope/ syncopal episode/ passed out, diastolic blood pressure abnormal, eyes hurt when he moves them/ eye sore, coronary and aortic valvular atherosclerosis, background emphysema and background osteopenia.An unknown corrective treatment was received.The patient outcome is reported as unknown for lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain, as recovered / resolved on an unknown date for unconscious/ syncope/ syncopal episode/ passed out, as unknown for confused temporarily upon awakening slightly elevated glucose of 126, auto neutrophils absolute # high, oid lacunar infarct in the anterior right external capsuie, ct head abnormal, stiffness as recovered / resolved on (b)(6) 2017 for relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing,diastolic blood pressure abnormal, auto lymphocytes % low,ambulation/ antalgic gait/ decreased cadence/ step-to pattern, vomiting, nausea, background emphysema, background osteopenia, as for coronary and aortic valvular atherosclerosis, r knee swelling, r knee pain, eyes hurt when he moves them/ eye socket sore, weakness, sweating.Ptc investigation was initiated and results are pending for the same.Seriousness criteria- hospitalization for unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsuie, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 112 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema.Additional information received on 13-sep-2018 from healthcare professional.Event of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain were added.Name of suspect product updated to synvisc one from synvisc.Clinical course updated.Text amended accordingly.Follow up information was received on 25-sep-2018.No new information was received.Additional information received on 28-nov-2018 from healthcare professional.Medical history was added.Indication of the suspect product was updated.Clinical course updated and text amended accordingly.Upon internal review on 09-jan-2019 with the clock start date of 28-nov-2018 the device malfunction incorrectly captured as 'yes' was corrected.
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Manufacturer Narrative
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Sanofi company comment for follow-up dated 28-nov-2018.The follow up information does not change the prior assessment of the case.This case concerns a patient who experienced syncope while on therapy synvisc one.With based on the available information, pharmacological plausibility can be established between the event and suspect product.However, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.
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Event Description
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Unconscious/ syncope/ syncopal episode/ passed out/ collapsed [syncope] slightly elevated glucose of 126 [blood glucose increased] oid lacunar infarct in the anterior right external capsuie [lacunar infarction] ([ct scan abnormal]) relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing [postural hypotension] auto neutrophils absolute # high [absolute neutrophil count increased] auto lymphocytes % low [lymphocyte percentage decreased] background osteopenia [osteopenia] background emphysema [emphysema] sweating [sweating] weakness [weakness] confused temporarily upon awakening [confused] vomiting [vomiting] nausea [nausea] diastolic blood pressure abnormal [blood pressure diastolic abnormal] eyes hurt when he moves them/ eye sockets sore [painful eye movement] coronary and aortic valvular atherosclerosis [arteriosclerosis] lightheaded and near syncopal [lightheadedness] knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well [therapeutic response decreased] ([eye pain], [unable to walk]) stiffness [stiffness] fall [fall] weight bearing activities [weight bearing difficulty] pain with weightbearing activities standing and twisting [pain upon movement] decreased range of motion [joint range of motion decreased] tenderness [tenderness] crepitus [joint crepitation] small abrasion [abrasion] acute calf pain/pain in right calf region [calf pain] right knee is twice the size of the left and is warm and red [swelling of r knee] joint pain [joint pain] case narrative: this case is cross referenced with case (b)(4).Based on the information received on 13-sep-2018, name of company suspect product updated to synvisc-one from synvisc.Initial information received on 13-sep-2018 from united states regarding an unsolicited valid serious case received from a patient.This case involves a 73 years old male patient who experienced unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsule, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema, sweating, weakness, lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, confused temporarily upon awakening, nausea, vomiting, coronary and aortic valvular atherosclerosis, diastolic blood pressure abnormal, stiffness, eye hurt when he moves them/ eye sock sore, fall, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain (unknown: latency), acute calf pain/pain in right calf region (latency: 8 months 6 days), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included caffeine allergy, drug hypersensitivity, wrist surgery, cataract, head injury, fracture, post-traumatic stress disorder, nasal septum deviation, swelling, pain in extremity, peripheral sensory neuropathy, sciatica, glossitis, onychomycosis, obese, colonoscopy normal ,rhinitis allergic and dry eye.The patient's past medical treatment included synvisc.The patient's family history included cerebrovascular accident with mother and cardiac disorder with brother and sister.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic posterior cervical pain, chronic upper and mid thoracic pain, arthralgia, atrial fibrillation, osteoarthritis diffusely, right knee most symptomatic lately/ djd, gastrooesophageal reflux disease, osteoarthritis, hypercholesterolaemia, hypothyroidism, osteoarthritis and ex-tobacco user with former smoker, cigarettes, 40 year(s).Previous treatment: self initiated treatment.Concomitant medications included omeprazole (protonix [omeprazole]) for gastrooesophageal reflux disease; famotidine (pepcid [famotidine]) for gastrooesophageal reflux disease; levofloxacin hemihydrate (levonox); oxycodone hydrochloride, paracetamol (acetaminophen w/oxycodone) for pain; levothyroxine (levothyroxine); pantoprazole (pantoprazole); ranitidine hydrochloride (rantidine); fentanyl (fentanyl); calcium chloride, potassium chloride, sodium lactate (lactated ringers); ondansetron (zofran [ondansetron]); meloxicam (meloxicam) for pain and inflammation; fluticasone propionate (fluticasone propionate); carboxymethylcellulose (carboxymethylcellulose); and citalopram hydrobromide (citalopram eg [citalopram hydrobromide]).On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate injection at 6ml once via intra- articular route for unilateral primary osteoarthritis of right knee.Right knee was prepped with betadine and ethyl chloride.Synvisc one injection was injected.Patient tolerated the procedure well and was discharged with stable vitals.On (b)(6) 2017, 1 day after synvisc injection, the patient developed an event of a serious unconscious/ syncope/ syncopal episode/ passed out (syncope) 1 day after starting use of hylan g-f 20 and sodium hyaluronate.The patient was hospitalized on the same day this event occurred.The patient sat up and got lightheaded and near syncopal and so he laid back down.Later, the patient did go ahead and get up out of bed and had made it to the kitchen and was sitting down when the patient suddenly went unconscious and collapsed to the floor.It was reported that he felt confused temporarily upon awakening (confusional state).On (b)(6) 2018, patient reported to the clinic with complaint of chronic pain in his posterior cervical, upper thoracic, mid thoracic region, which he had since 1989.He mentioned that his pain was aggravated by any movement and he was receiving chiropractic care for the same.On (b)(6) 2018, patient reported again for follow up of his chronic pain and reported that it was dull and aching in nature and was radiating to his anterior right elbow.The pain aggravated upon rising from a chair and sitting was difficult.On (b)(6) 2018, patient reported to the clinic with for his chronic pain and rated his pain 2 on a scale of 10.His pain was improving and it was easier for him to sit now.On (b)(6) 2018, patient followed up at the clinic for his chronic pain and stated it remained the same as his last visit.He was given chiropractic manipulative treatment and compensatory adjustment.On (b)(6) 2018, the patient reported for follow up of his chronic pain and he was showing improvement, his hypomobility and tautness were decreasing along with decreased vertebral fixation.On (b)(6) 2018, patient developed acute calf pain/pain in right calf region (latency: 8 months 6 days) which developed after walking and he rated it 8 on a scale of 10.His pain was worse with walking and he had difficulty bearing weight on his right leg.On (b)(6) , patient followed up for his calf pain and was given manual therapy as a corrective after which he felt immediate relief.The treatment plan for his acute pain was worked out which included therapeutic exercises, neuromuscular reeducation, isometrics and lifestyle modifications.On 18-jul-2018, patients calf pain was dull achy in nature and he mentioned it had improved significantly.The chiropractic adjustments were performed along with manual therapy which included iastm.On (b)(6) 2018, patient rated his calf pain at 8 on a scale of 10 and he reported that his symptoms had moderately worsened.The routine manual and chiropractic treatments were given.On (b)(6) 2018, his acute calf pain was 6 on a scale of 10 and his condition had improved since last visit.The patient was advised to use a cold pack for 15 minutes on the pain region.On (b)(6) 2018, his calf pain was 5 on a scale of 10 and he was feeling better.On (b)(6) 2018, his calf pain was 4 on a scale of 10 and he underwent his routine chiropractic adjustment using manual thompson technique and also manual therapy of iastm for his calf pain.On(b)(6) 2018, patient visited the clinic for follow up of his acute pain and stated that his condition had improved significantly, he rated his pain 1 on a scale of 10.Along with the manual thompson technique, patient also had a pelvic region cmt performed using the thompson drop table and the routine iatsm manual therapy.On (b)(6) 2018, during his follow up visit, patient reported his calf pain was 2 on a scale of a 10 and was at its worst when his heels would touch the ground.The patient felt immediate relief after his manual therapy.A dynamic tape was applied to his right calf to aid in extra achilles tendon support.On (b)(6) 2018, patient reported he had dull achy calf pain which he rated at 4 on a scale of 10.He reported that he had exacerbated his condition slightly by performing yard work.The routine manual and chiropractic treatment was given.On (b)(6) 2018, the patient reported again for follow up of his right calf pain and rated his pain at 0 on a scale of 10, he no longer had any symptoms of pain in his calf region and had made significant improvement and all his functional goals had been met.The patient was educated about his preventive maintenance program and was advised to follow up for his maintenance treatment, as desired.On (b)(6) 2018, patient reported for follow up of his pain in right calf region and he had no pain and was doing well.On (b)(6) -2018, he returned for his maintenance treatment and was doing well with no reported pain.The patient was given chiropractic adjustments as his maintenance treatment.The patient had one episode of nausea and vomiting en route to the hospital on (b)(6) 2018.On admission the patient was diagnosed with weakness, sweating, unconscious/ syncope/ syncopal episode/ passed out and his vitals were normal.Comprehensive metabolic profile was universally normal except slightly elevated glucose of 126.The ct did show an oid lacunar infarct in the anterior right external capsule, orthostatic vital signs did demonstrate a significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing.During hospitalization his auto lymphocytes % low (lymphocyte percentage decreased), serious auto neutrophils absolute # high (neutrophil count increased) and ct angiogram of the chest with reformatting showed the background osteopenia (osteopenia), mild to moderate degree of background emphysema, chronic appearing compression deformities of t5, t6, t9, t12, and l1 , exaggerated upper thoracic kyphosis.The patient had knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well (therapeutic response decreased) with symptoms of r knee swelling and r knee pain with ambulation/ antalgic gait/ decreased cadence/ step-to pattern and denied headache or neck discomfort.He doesn't take aspirin daily.He states he doesn't have diabetes or hypertension and was alert and oriented x3 and in no acute distress.On reexamination, patient had normal cbc and chemistry profile.Patient remains neurologically intact.Head ct showed some mild small vessel disease and an old lacunar infarct.Attempted to do orthostatic vital signs but with difficulty.The patient was discharged on (b)(6) 2017.On unknown date, patient experienced fall and was having pain.He was also having pain with weightbearing activities standing and twisting.Patient also experienced from joint pain and decreased range of motion.He also showed mild crepitus and mild tenderness.A small abrasion was also observed on his body.Relevant laboratory test results included: activated partial thromboplastin time - on (b)(6) 2017: 27.3 [11:18 est] albumin globulin ratio (1.1 - 1.6 unk) - on (b)(6) 2017: 1.0 unk [low] blood glucose increased (70 - 105 mg/dl) - on (b)(6) 2017: 126 mg/dl [time - 11:18]; on an unknown date: 126 mg/dl [high] blood pressure diastolic - on (b)(6) 2017: 101 unk [abnormal] blood pressure measurement - on (b)(6) 2017: 133/67 mmhg [time- 12:42 est]; on an unknown date: 135/56 mmhg blood urea decreased (12 - 20 unk) - on (b)(6) 2017: 11 unk body temperature - on an unknown date: 98 f electrocardiogram - on (b)(6) 2017: [a.Fib, rate 83] heart rate - on (b)(6) 2017: 81 unk [bpm time- 12:42 est]; on an unknown date: 86 unk [units- bpm] international normalised ratio - on (b)(6) 2017: 1.0 [anticoagulation monitoring] lymphocyte percentage - on (b)(6) 2017: 17.6 % [low] mean arterial pressure - on (b)(6) 2017: 89 mmhg [time- 12:42 est] neutrophil count - on (b)(6) 2017: 7.8 unk [units- 10*3/mcl time- 11:18 est] oxygen saturation - on (b)(6) 2017: 97 % [time- 12:42 est] respiratory rate - on (b)(6) 2017: 18 unk [br/min time- 12:42 est]; on an unknown date: 16 unk [br/min] corrective treatment: chiropractic treatment, manual thompson therapy and cold pack for acute calf pain/pain in right calf region; not reported for rest outcome: unknown for lightheaded and near syncopal, knee pain was pretty severe/ stili painful, so not performing full range of motion or weightbearing well, of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain, as recovered / resolved on an unknown date for unconscious/ syncope/ syncopal episode/ passed out, as unknown for confused temporarily upon awakening slightly elevated glucose of 126, auto neutrophils absolute # high, oid lacunar infarct in the anterior right external capsule, ct head abnormal, stiffness as recovered / resolved on (b)(6) 2017 for relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 1 1 2 standing, diastolic blood pressure abnormal, auto lymphocytes % low, ambulation/ antalgic gait/ decreased cadence/ step-to pattern, vomiting, nausea, background emphysema, background osteopenia, as for coronary and aortic valvular atherosclerosis, r knee swelling, r knee pain, eyes hurt when he moves them/ eye socket sore, weakness, sweating; recovered for ptc investigation was initiated and results are pending for the same.Seriousness criteria- hospitalization and medically significant for unconscious/ syncope/ syncopal episode/ passed out, slightly elevated glucose of 126, oid lacunar infarct in the anterior right external capsuie, relative postural hypotension/ significant drop in systolic blood pressure from 1 44 supine to 112 standing, auto neutrophils absolute # high, auto lymphocytes % low, background osteopenia, background emphysema.Additional information received on 13-sep-2018 from healthcare professional.Event of fall, pain in weight bearing activities, pain in weight bearing activities and twisting, decreased range of motion, tenderness, crepitus, small abrasion and joint pain were added.Name of suspect product updated to synvisc one from synvisc.Clinical course updated.Text amended accordingly.Follow up information was received on 25-sep-2018.No new information was received.Additional information received on 28-nov-2018 from healthcare professional.Medical history was added.Indication of the suspect product was updated.Clinical course updated and text amended accordingly.Upon internal review on (b)(6) 2019 with the clock start date of (b)(6) 2018 the device malfunction incorrectly captured as 'yes' was corrected.Additional information received on 15-mar-2019 from lawyer.Case classification of legal added.Medical history of chronic posterior cervical pain, chronic upper and mid thoracic pain.Event of acute calf pain/pain in right calf region added.Clinical course updated.Text amended accordingly.
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