Model Number 103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Seizures (2063); Vomiting (2144); Sleep Dysfunction (2517); No Code Available (3191)
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Event Date 10/08/2015 |
Event Type
malfunction
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Event Description
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It was reported by the patient's partner that the patient had had too many grand mals since implant and that his seizures had steadily gotten worse.He indicated that the patient had had around 20 grand mal seizures since having the vns implanted and had many aura type seizures daily.No further relevant information has been received to date.
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Event Description
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It was reported by the patient's partner that the patient would be getting their device explanted.No known surgical intervention has occurred to date.
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Event Description
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It was reported that the patient's vns was explanted.Product return is not expected as the hospital historically has discarded explanted products.No further relevant information has been received to date.
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Event Description
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It was reported through clinic notes that swiping the magnet made the patient retch.In the titration notes, it was noted that the patient had gagging and drooling with stimulation as well.Finally, it was reported that the patient had pain in the left side of the neck and hoarseness with stimulation.It was noted that the patient's generator was programmed off and the patient was referred to surgery as he no longer needed the vns.No further relevant information has been received to date.
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Event Description
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It was reported via return fax that device disablement and explant was for patient comfort and not to preclude a serious injury.The reason for explant was the patient's adverse events.It was noted that the relationship of the patient's seizures to the vns was unclear.The patient had a change in general tonic clonic seizures in 2017-2018 but the patient improved in (b)(6) 2018 with medication changes.It was also noted that the patients retching, grunting, lots of phlegm, snoring and coughing at night were possibly related to activations but that the relationship was unclear.No further relevant information has been received to date.
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Search Alerts/Recalls
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