Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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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 experienced ineffective therapy.In addition, the patient reportedly feels the stimulation in an unintended location.As a result, surgical intervention may be pending to address this issue.
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Event Description
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Follow up revealed that stimulation in the undesired location is causing a burning, numbing feeling.
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Search Alerts/Recalls
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