Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Event and therapy dates are estimated.The results/method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2020-48290.Related manufacturer reference number: 1627487-2020-48291.Related manufacturer reference number: 1627487-2020-48292.Related manufacturer reference number: 1627487-2020-48294.It was reported that patient has infection at an unknown site.Surgical intervention is expected to address the issue at a later date.
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Manufacturer Narrative
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Leads and anchors are no longer reportable with the new information available.
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Event Description
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Additional information received, indicated that patient underwent surgical intervention wherein the system was explanted and the infection was at the ipg site only.
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Search Alerts/Recalls
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