Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Date 02/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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The patient's daughter the patient experienced difficulty moving her legs following an implant procedure on (b)(6) 2018.As such, the physician decided to remove the patient's scs system that same day.
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Event Description
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Follow-up information revealed the patient is now able to walk with a walker and no other weakness has been reported.
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Search Alerts/Recalls
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