| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Stroke/CVA (1770); Numbness (2415); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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May have had a rare complication of spinal cord stroke/a possible spinal cord stroke described as having numbness of the feet, anus, scrotum, knees, calves, ankle, and shins (spinal stroke - numbness of lower extremities, anal hypoesthesia, genital hypoesthesia - condition worsened).With the numbness he was not able to sleep - difficulty sleeping.Received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles - off label dosing.Received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles - extra dose administered.Case narrative: initial information received from united states on (b)(6) 2022 regarding an unsolicited valid serious case received from the patient.This case involves a 64 years old male patient who had a rare complication of spinal cord stroke/a possible spinal cord stroke described as having numbness of the feet, anus, scrotum, knees, calves, ankle, and shins, with the numbness he was not able to sleep and received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles with the use of medical device hylan g-f 20, sodium hyaluronate - synvisc.The consumer reported that the consumer has a history of renal cancer and he has one kidney; that the cancer was in 2011 and he had his kidney to burst; that he has been on blood thinners for deep vein thrombosis (dvts) in the leg; that the blood thinners began after the renal cancer; that he began on warfarin in 2011; that he remained on warfarin until 2012 after he and his prescriber weaned him off due to his level of health; that in 2019 a doppler and blood test showed a dvt in leg; that the consumer was started back on xarelto; that in this time the consumer has used xarelto and will stop xarelto if he has a procedure; that the consumer halted the xarelto while he was having surgery to both rotary cuffs; that he did not go off xarelto to have the synvisc; that he takes xarelto; and that he did have right hip replacement surgery 2-year ago by the prescriber on (b)(6) 2022, the patient received synvisc injection (solution for injection) (strength: 16 mg/ 2 ml) (with an unknown dose, route, frequency, batch number and expiry date) for osteoarthritis.Information regarding the batch number and expiry date was requested.First time product used : yes.Patient questions regarding an ae.He reports that on (b)(6) 2022 he received 2 syringes, that his doctor had combined into one, and administered in his left knee.He states that the following day he developed numbness in his left foot, then around his tailbone, and then in his right foot.He is asking if this could be because he received the 2 injections as one at the same time (off label use) (extra dose administered) (same day).A consumer reporting new onset symptom of numbness to the left foot, numbness to the pelvic region, and numbness to the right foot after using the synvisc off-label described as receiving 1-synvisc injection on week one then followed by 2-combined synvisc injections on week two.The consumer reported that he asked the prescriber to administer 2-synvisc injections on week two due to having a fear of needles; that the prescriber verbalized that would not be a problem and then on (b)(6) 2022, he received the combined 2-injections; that the injections were combined into one syringe and then injected; that the synvisc was injected in to the left knee for osteoarthritis; that 1.5 days later the numbness was experienced in the left foot; that the numbness became progressively worse described as spreading to the pelvic area and then to the right leg down to the right foot (hypoaesthesia) (condition aggravated) (latency same day); that the consumer had a magnetic resonance imaging (mri) of the lower extremity to include the spine, pelvis, and legs due to the numbness, on (b)(6) 2022; that he has a follow up with the neurologist to see the mri; and that he also had an electromyography (emg), on (b)(6) 2022 do to the numbness; that the emg showed no issue.The consumer reported that with the numbness he was not able to sleep (insomnia); that he is wetting himself; that he was an active and healthy person; that if these symptoms get worse or cannot be treated, he will not be able to take it; that he started become numb a day after getting the second injection of synvisc; that he had the second injection off-label as a combined 2nd and 3rd injection due to not liking needles; that he was advised to ice the leg for 2-days and not the 1-day if he had a regular injection; that he came in on (b)(6) 2022 to get the second injection but told the prescriber he did not like needles; that then the prescriber combined the synvisc into one injection; that on the night of (b)(6) 2022 the left foot became numb; that the following day, on (b)(6) 2022, the numbness continued; into the calf, ankle, and shins (hypoaesthesia) (anal hypoaesthesia) (medically significant); that he had numbness with feeling he had to go but not being able to feel he was going with urination; that he was unable to feel the toilet paper wiping himself/scortum (genital hypoaesthesia)(medically significant); that still to this day he has these issues; that his prescriber saw him on (b)(6) 2022; that the prescriber told the consumer is was a coincidence; that he was referred to physical therapy (pt); that he went to pt but pt was unable to treat due to the numbness; that the consumer saw a neurologist; that the neurologist ruled out neuropathy ; that he had a magnetic resonance imaging(mri) of the thoracic region; that he was ruled out for ; that he was sent to a chiropractor but was no help; that he has seen a spine- specialist; that the spine specialist recommended removal of a cyst and spinal infusion; that the consumer did have the surgery and was placed in a back brace; that he has no change in his issues; that he has had more mris of the brain, neck, spine, thoracic; that he had both with and without contrast; that he did have blood work to rule out things such as infection; that the imaging and blood work showed nothing; that he had followed up with the prescriber who talked with a college to discuss the issues; that there was nothing apparent that would cause this condition; that he was thinking the consumer may have had a rare complication of spinal cord stroke (spinal stroke) after an unknown latency (medically significant); that the prescriber was wanting him to try a neural medication for his symptoms but he does not want to go through the listed side effects; and that he does have an upcoming appointment for another specialist in a few months.Relevant laboratory test results included: blood test - on an unknown date: nothing.Electromyogram - on (b)(6) 2022: no issues.Magnetic resonance imaging - on (b)(6) 2022: not provided.Magnetic resonance imaging head - on an unknown date: showed nothing.Magnetic resonance imaging neck - on an unknown date: showed nothing.Magnetic resonance imaging spinal - on an unknown date: showed nothing.Magnetic resonance imaging thoracic - on an unknown date: cauda equina syndrome.Action taken: not applicable for all events.Corrective treatment: chiropractor, surgery and was placed in a back brace, physical therapy.Outcome: unknown for off label use and was not recovered / not resolved for all the other events.A product technical complaint was initiated on (b)(6) 2022 for synvisc with global ptc number: (b)(4).The sample status of the ptc was not available.The product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 26-oct-2022 with summarized conclusion as no assessment possible.Additional information was received on 20-sep-2022 from the quality department.Global ptc number added.Formulation and strength added.Text amended accordingly.Additional information was received on 26-oct-2022 from the quality department.Ptc result was added.Text amended accordingly.Additional information was received on 10-feb-2023 from the patient.Additional events spinal cord stroke and insomnia was added.Case updated to valid serious case from a non-serious case.Text amended accordingly.
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Event Description
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May have had a rare complication of spinal cord stroke/a possible spinal cord stroke described as having numbness of the feet, anus, scrotum, knees, calves, ankle, and shins [spinal stroke] ([numbness of lower extremities], [anal hypoesthesia], [genital hypoesthesia], [condition worsened]) with the numbness he was not able to sleep [difficulty sleeping] received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles [off label dosing] received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles [extra dose administered] case narrative: initial information received from united states on 20-sep-2022 regarding an unsolicited valid serious case received from the patient.This case involves a 64 years old male patient who had a rare complication of spinal cord stroke/a possible spinal cord stroke described as having numbness of the feet, anus, scrotum, knees, calves, ankle, and shins, with the numbness he was not able to sleep and received the 2 injections as one at the same time/off-label as a combined 2nd and 3rd injection due to not liking needles with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The consumer reported that the consumer has a history of renal cancer and he has one kidney; that the cancer was in 2011 and he had his kidney to burst; that he has been on blood thinners for deep vein thrombosis (dvts) in the leg; that the blood thinners began after the renal cancer; that he began on warfarin in 2011; that he remained on warfarin until 2012 after he and his prescriber weaned him off due to his level of health; that in 2019 a doppler and blood test showed a dvt in leg; that the consumer was started back on xarelto; that in this time the consumer has used xarelto and will stop xarelto if he has a procedure; that the consumer halted the xarelto while he was having surgery to both rotary cuffs; that he did not go off xarelto to have the synvisc; that he takes xarelto; and that he did have right hip replacement surgery 2-year ago by the prescriber on (b)(6) 2022, the patient received synvisc injection (solution for injection) (strength: 16 mg/ 2 ml) (with an unknown dose, route, frequency, batch number and expiry date) for osteoarthritis.Information regarding the batch number and expiry date was requested.First time product used : yes patient questions regarding an ae.He reports that on 9/3 he received 2 syringes, that his doctor had combined into one, and administered in his left knee.He states that the following day he developed numbness in his left foot, then around his tailbone, and then in his right foot.He is asking if this could be because he received the 2 injections as one at the same time (off label use) (extra dose administered) (same day).A consumer reporting new onset symptom of numbness to the left foot, numbness to the pelvic region, and numbness to the right foot after using the synvisc off-label described as receiving 1-synvisc injection on week one then followed by 2-combined synvisc injections on week two.The consumer reported that he asked the prescriber to administer 2-synvisc injections on week two due to having a fear of needles; that the prescriber verbalized that would not be a problem and then on (b)(6) 2022, he received the combined 2-injections; that the injections were combined into one syringe and then injected; that the synvisc was injected in to the left knee for osteoarthritis; that 1.5 days later the numbness was experienced in the left foot; that the numbness became progressively worse described as spreading to the pelvic area and then to the right leg down to the right foot (hypoaesthesia) (condition aggravated) (latency same day); that the consumer had a magnetic resonance imaging (mri) of the lower extremity to include the spine, pelvis, and legs due to the numbness, on (b)(6) 2022; that he has a follow up with the neurologist to see the mri; and that he also had an electromyography (emg), on (b)(6) 2022 do to the numbness; that the emg showed no issue.The consumer reported that with the numbness he was not able to sleep (insomnia); that he is wetting himself; that he was an active and healthy person; that if these symptoms get worse or cannot be treated, he will not be able to take it; that he started become numb a day after getting the second injection of synvisc; that he had the second injection off-label as a combined 2nd and 3rd injection due to not liking needles; that he was advised to ice the leg for 2-days and not the 1-day if he had a regular injection; that he came in on 02sep2022 to get the second injection but told the prescriber he did not like needles; that then the prescriber combined the synvisc into one injection; that on the night of 02sep2022 the left foot became numb; that the following day, on 03sep2022, the numbness continued; into the calf, ankle, and shins (hypoaesthesia) (anal hypoaesthesia) (medically significant); that he had numbness with feeling he had to go but not being able to feel he was going with urination; that he was unable to feel the toilet paper wiping himself/scortum (genital hypoaesthesia)(medically significant); that still to this day he has these issues; that his prescriber saw him on (b)(6) 2022; that the prescriber told the consumer is was a coincidence; that he was referred to physical therapy (pt); that he went to pt but pt was unable to treat due to the numbness; that the consumer saw a neurologist; that the neurologist ruled out neuropathy ; that he had a magnetic resonance imaging(mri) of the thoracic region; that he was ruled out for ; that he was sent to a chiropractor but was no help; that he has seen a spine- specialist; that the spine specialist recommended removal of a cyst and spinal infusion; that the consumer did have the surgery and was placed in a back brace; that he has no change in his issues; that he has had more mris of the brain, neck, spine, thoracic; that he had both with and without contrast; that he did have blood work to rule out things such as infection; that the imaging and blood work showed nothing; that he had followed up with the prescriber who talked with a college to discuss the issues; that there was nothing apparent that would cause this condition; that he was thinking the consumer may have had a rare complication of spinal cord stroke (spinal stroke) after an unknown latency (medically significant); that the prescriber was wanting him to try a neural medication for his symptoms but he does not want to go through the listed side effects; and that he does have an upcoming appointment for another specialist in a few months.Relevant laboratory test results included: blood test - on an unknown date: [nothing].Electromyogram - on (b)(6) 2022: [no issues].Magnetic resonance imaging - on 16-sep-2022: [not provided] magnetic resonance imaging head - on an unknown date: [showed nothing].Magnetic resonance imaging neck - on an unknown date: [showed nothing].Magnetic resonance imaging spinal - on an unknown date: [showed nothing].Magnetic resonance imaging thoracic - on an unknown date: [cauda equina syndrome] action taken: not applicable for all events corrective treatment: chiropractor, surgery and was placed in a back brace, physical therapy outcome: unknown for off label use and was not recovered / not resolved for all the other events a product technical complaint was initiated on 20-sep-2022 for synvisc with global ptc number: 100263301.The sample status of the ptc was not available.The product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.The final investigation was completed on (b)(6) 2022 with summarized conclusion as no assessment possible.Additional information was received on (b)(6) 2022 from the quality department.Global ptc number added.Formulation and strength added.Text amended accordingly.Additional information was received on (b)(6) 2022 from the quality department.Ptc result was added.Text amended accordingly.Additional information was received on (b)(6) 2023 from the patient.Additional events spinal cord stroke and insomnia was added.Case updated to valid serious case from a non-serious case.Text amended accordingly.Based on the previously received information, annex e codes were added in mir form.
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