Model Number 3186 |
Device Problem
Migration (4003)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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: 3006705815-2020-31428.It was reported the patient's leads migrated.As a result, surgical intervention may occur at a later date to address the issue.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Additional information received indicates that the patient had their leads replaced.Effective therapy was established post-operatively.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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