Model Number 3383 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Sweating (2444)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) manufacturer¿s evaluation: the complaint of infection can not be confirmed via laboratory testing.Sjm 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 3 of 5.Reference mfr.Report# 1627487-2016-04091.Reference mfr.Report# 1627487-2016-04092.Reference mfr.Report# 1627487-2016-04095.Reference mfr.Report# 1627487-2016-04096.It was reported the patient (australia) experienced infection along with pain and inflammation at the trial lead incision site.As a result, the leads were explanted.
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Event Description
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Device 3 of 5.Reference mfr.Report# 1627487-2016-04091; reference mfr.Report# 1627487-2016-04092; reference mfr.Report# 1627487-2016-04095; reference mfr.Report# 1627487-2016-04096.Additional information received identified the patient received antibiotics and the infection has resolved.
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Search Alerts/Recalls
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