Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Fever (1858); Pain (1994)
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Event Date 12/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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 2 of 2: reference mfr.Report# 1627487-2017-00381.It was reported the patient ((b)(6)) was presented at the emergency department for pain at the ipg site and fever.Ct scan revealed abscess at the ipg site radiating up to the lead.Subsequently, the scs system was explanted.
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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 2 of 4.Reference mfr.Report# 1627487-2017-00381, 1627487-2017-00465, 1627487-2017-00517.Additional information received identified the patient received two leads and two anchors.Anchors had the same lot number.Additional devices are added as device 3 and 4.
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Search Alerts/Recalls
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