Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930)
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Event Date 12/03/2019 |
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 subsequent submission.
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Event Description
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Related manufacturer reference number: 3006705815-2019-05024.3006705815-2019-05025.1627487-2019-14169.It was reported that the patient had a full system explant on (b)(6) 2019 due to the patient's leads and anchors becoming exposed, causing patient to develop an infection.
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Manufacturer Narrative
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An event of a staph infection was reported to abbott.It was conveyed that the infection originates at the lead site(s) and anchor site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead site(s) and anchor site(s).Based on the documents reviewed, the source of the infection remains unknown.
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Event Description
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Manufacturer report number 3006705815-2020-00731.
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Search Alerts/Recalls
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