Model Number RNS-320-K - FGI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Intracranial Hemorrhage (1891); Pain (1994)
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Event Date 08/11/2023 |
Event Type
Injury
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Event Description
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A few months after implant the patient reported skull pain.Over the years he occasionally reported skull pain, headaches and more recently pain throughout his body.The patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.He is currently intubated and has a feeding tube.The cause of the patient's pain was not determined.
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Manufacturer Narrative
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(b)(4).The explanted product was not returned to neuropace for analysis.
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Manufacturer Narrative
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(b)(4).The explanted product was not returned to neuropace for analysis.
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Event Description
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A few months after implant ((b)(6)) the patient reported skull pain.The patient continued to occasionally report skull pain and headaches for approximately five years post implant.More recently he reported pain throughout his body.In (b)(6) 2023, the patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.Prior to explant, the doctor reported that the patient had scarring around the subdural strip lead, there was no report of hemorrhaging.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.The cause of the patient's pain was not determined.
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Search Alerts/Recalls
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