Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Skin Inflammation (2443)
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Event Date 10/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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Event date estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number:1627487-2019-11995.It was reported that there was an blister at the lead incision site.The patient was prescribed antibiotics and a cream.The patient underwent surgical intervention due to an ipg site infection captured in related manufacturer reference number: 1627487-2019-11990, wherein the entire scs system was explanted on an unknown date.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient blister is now healed.The patient had their entire scs system explanted and replaced on (b)(6) 2019.
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Search Alerts/Recalls
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