Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/02/2021 |
Event Type
Injury
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Event Description
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It was reported that when the patient is laying down her generator sticks up and is causing chest discomfort.The patient was referred to neurosurgery for a pocket revision.No known surgical intervention has occurred to date.No other relevant information has been received to date.
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Manufacturer Narrative
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(b)(4).Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
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Manufacturer Narrative
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F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.Note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.
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Event Description
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The patient underwent a pocket revision for patient comfort only as they were experiencing chest discomfort.Per the physician, the generator protrusion was due to the generator shifting laterally.
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Search Alerts/Recalls
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