|
Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Memory Loss/Impairment (1958); Dysphasia (2195); Cognitive Changes (2551)
|
Event Date 05/16/2013 |
Event Type
Death
|
Event Description
|
It was reported the patient died in their sleep overnight.The stimulator was noted to be switched off.The patient was hospitalized prior to death for memory problems.The cause of death was unknown and an autopsy was performed but no clear cause of death was noted.Tests were still ongoing.It was unknown if the death was device related or not.Additional information reported the patient had been hospitalized to investigate and objectivize complaints of memory problems, continued episodes of absent behavior, word finding problems, and not being able to establish contact with others.Stimulation amplitude was decreased but the problems persisted and memory problems increased.During the stay the patient was found dead in their bed.Additional information from the physicians reported that a sudden unexpected death based on epilepsy was one possible cause of death.Epilepsy was only suspected and not proven.A second possibility was an arrhythmia with finally ventricular fibrillation or asystole which could explain the absences, the fall beside the bed, and loss of consciousness in the cafeteria.The physician indicated that it was hard to say if the death was caused by the stimulator, but they suspected not.The stimulator was turned off at night and the patient died overnight.The stimulators were noted to be off at the time of death.The absences occurred not only when the stimulator was off.The night before death the patient had noted the stimulator was programmed fine because they felt really good again.The autopsy showed no macroscopic organ abnormalities and no histological abnormalities.Further histological examination was to be d one.Such results did not exclude epilepsy nor arrhythmia as cause of death.There was no clear explanation of death at the time.The differential diagnosis remained as sudden unexpected death with epilepsy or a cardiac arrhythmia.Since the stimulator was switched off at the time of death it was particularly unlikely that the stimulation would have played a role in the death.There was no reason to think that the stimulation lead to epilepsy.Two eeg¿s and 24 hour eec showed no epileptic form of activity.Additionally no major deviations were observed.There was only congestive to hemorrhagic edema seen in the lung biopsies that could not fit asphyxia.It was questionable if it was a result of seizure.Brain dissection would still be executed but provisionally by exclusion it was assumed an epilepsy related death.The physician noted it was there personal opinion that the death was not unrelated to the stimulator.Refer to manufacturer report # 9614453-2012-00006 and 9614453-2012-00007 for information on previous symptoms of absent behavior, word finding problems, and not being able to establish contact.
|
|
Manufacturer Narrative
|
Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator.(b)(4).
|
|
Search Alerts/Recalls
|
|
|