Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Numbness (2415)
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Event Date 10/23/2017 |
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 the patient experienced ineffective stimulation with right sided numbness and pain.Clinical specialist attempted reprogramming the patient multiple times without success.As a result, the patient may be awaiting lead revision.
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Event Description
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Follow up information identified the physician explanted the patient¿s lead.
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Search Alerts/Recalls
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