Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Dizziness (2194)
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Event Date 10/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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Manufacture 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2017-07019.It was reported (australia) the patient was admitted to the hospital due to experiencing dizziness while walking as the result of hematoma at the lead site.As of (b)(6) 2017 the symptoms were resolved.
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Event Description
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Device 1 of 2, reference mfr.Report# 1627487-2017-07019.Additional information received identified the issue has resolved.
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Search Alerts/Recalls
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