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 06/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number 3006705815-2021-03342.It was reported that patient experienced pain at the lead site due to infection.As a result, patient underwent surgical intervention wherein the entire system was explanted to address the issue.
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Manufacturer Narrative
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The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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