Model Number 3189 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Erosion (1750)
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Event Date 08/21/2018 |
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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This report is reference to a device being used for off-label use.It was reported that one of the patient's supraorbital leads had eroded through the skin.As a result, the patient plans to undergo surgical intervention.
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Event Description
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Follow up revealed that the patient's lead was explanted, which addressed the issue.
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Search Alerts/Recalls
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