Model Number 3662 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Date 12/07/2017 |
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 experienced discomfort at the scs ipg site.As a result, surgical intervention may be undertaken at a later date to address the issue.
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Event Description
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Additional information received that surgical intervention was undertaken on (b)(6) 2018 wherein the scs ipg was relocated to the other side.
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Search Alerts/Recalls
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