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Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 07/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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It was reported the patient had developed subdural hematomas and was unable to move their legs following a system implant.In turn, surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted.The patient regained movement in their legs.Reportedly, the patient has been discharged from hospital and is recovering.
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Search Alerts/Recalls
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