Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Weakness (2145)
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Event Date 10/04/2017 |
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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It was reported that the patient (clinical study) experienced leg weakness following a permanent implant on (b)(6) 2017.As a result, the patient was kept overnight at the hospital.The physician re-evaluated the patient the following day and confirmed that the issue was still present.As a result, surgical intervention was undertaken to explant the patient's system.
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Event Description
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Follow up revealed that the issue of leg weakness was experienced in both legs during recovery.
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Event Description
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Further follow-up indicates the patient's leg weakness was due to an hematoma.
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Search Alerts/Recalls
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