Model Number 3086 |
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 08/09/2015 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's evaluation: the complaint of infection cannot be confirmed via laboratory testing.(b)(4).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 1 of 2: reference mfr.Report#: 1627487-2015-05448.On (b)(6) 2015, the patient underwent a trial procedure and was implanted with two leads.Three days later the patient developed a fever.On (b)(6) 2015, the patient's leads were removed due to the patient being diagnosed with cellulitis.The patient will remain on antibiotics until otherwise.The patient's date of birth is unknown.
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Manufacturer Narrative
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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 1 of 2.Reference mfr.Report#: 1627487-2015-05448.Follow-up revealed the patient's issue has resolved.
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Search Alerts/Recalls
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