Model Number 3166 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cellulitis (1768)
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Event Date 01/28/2018 |
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.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.Manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2018-01792.It was reported the patient was presented at the emergency room for a tender site near her left occipital lead.The patient was diagnosed with cellulitis near the left occipital lead and was put on oral antibiotics.
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Event Description
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Device 2 of 2, reference mfr.Report# 1627487-2018-01792.Additional information received identified there was no drainage observed and the tenderness has resolved.
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Search Alerts/Recalls
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