Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Unspecified Infection (1930)
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Event Date 07/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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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: 1627487-2019-09321, related manufacturer reference number: 1627487-2019-09322, related manufacturer reference number: 1627487-2019-09324.It was reported that an infection was present at the lead site.The patient experienced severe headaches for approximately three weeks and drainage at the lead site.The patient was given antibiotics over the course of several days to address the infection.The patient's scs system was later explanted and the infection was resolved over time.
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Manufacturer Narrative
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A patient had their system explanted due to infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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Search Alerts/Recalls
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