Model Number 3189 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 02/01/2020 |
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# 1627487-2020-23281.It was reported the patient underwent an unrelated surgical procedure, during which the leads were accidentally cut.As the result, the patient may undergo surgical intervention to address the issue.
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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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Event Description
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Further follow-up indicates the patient had surgical intervention on (b)(6) 2020, during which the existing cut leads were explanted and replaced.Issue resolved and therapy has been restored.
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Search Alerts/Recalls
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