Model Number TLEAD1058-50B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Pain (1994)
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Event Date 07/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing records were reviewed and no relevant nonconformities were found.The device was not returned.
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Event Description
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It was reported to nevro that the patient experienced pocket pain and a fever.Nevro attempted to obtain additional information regarding the nature of the issue but none was available.The device was removed and there have been no reports of further complications regarding this event.
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Manufacturer Narrative
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This report is to update based on new information.
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Event Description
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Follow-up indicated that the patient's pocket pain and fever were due to an infection caused by a bandage changed at home.The physician drained the infection and there have been no reports of further complications regarding this event.
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Search Alerts/Recalls
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