Model Number SC-2408-74 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Paralysis (1997); No Code Available (3191)
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Event Date 07/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: sc-2408-74, serial/lot: (b)(4), description: avista mri perc lead kit 74 cm.
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Event Description
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A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
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Event Description
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A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
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Manufacturer Narrative
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Additional information was received the edema was located in the spine of the patient.
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Event Description
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A report was received that following the implant procedure the patient experienced leg paralysis symptoms.The physician switched off the stimulation and will continue to monitor.The physician does not believe that the symptoms are device related, but does not know the cause of the symptoms.During the procedure, the left side of the dura was punctured.The physician started refilling the infusion and punctured again.When placing the lead it was difficult to apply torque and did not enter the cervical spine, so a thoracic incision needle was inserted and the lead was placed at the tip pf c2.The patient now has feeling in the right leg but it is hard to get up and swelling has resolved.
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Manufacturer Narrative
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Age: 75 years.Additional information was received that following the implant procedure the patient experienced edema and was only able to bend and stretch the right leg.The patient continues rehabilitation and is recovering.
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Search Alerts/Recalls
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