Model Number 103 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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Event Date 04/01/2015 |
Event Type
malfunction
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Event Description
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It was reported that the patient's seizures have been increasing.The physician feels that the patient's device may be nearing end of service.The patient was referred to surgeon.It is unknown whether or not the increase in seizures was above the patient's pre-vns baseline frequency.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical intervention has been performed to date.
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Manufacturer Narrative
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Event Description
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It was reported that the patient's replacement never occurred and he has now been referred for generator replacement due to neos (near end of service).The new referral due to neos indicates that the patient was most likely not at neos when the increase in seizures was first reported as the initial report was over 1 year ago.No known surgical interventions have been performed to date.
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Event Description
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It was noted the patient was referred for a model 106 generator replacement as the patient is at a great risk for sudep.The patient was referred for generator replacement surgery; however, no know surgical interventions have been occurred to date.
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Event Description
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It was reported by the company representative that the device is not neos = yes (near end of service), but is still at ifi = yes (intensified follow-up indicator), and is still showing yellow.No known surgical interventions have occurred to date.
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Event Description
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It was later reported the patient is having a big increase in seizures and the device is at near end-of-service.
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Search Alerts/Recalls
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