Model Number TLEAD1058-50B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Date 11/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing records were reviewed, and no non-conformities 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 a skin reaction to the dressing used during the trial.The leads were removed and the patient is recovering.The physician does not believe this was related to the device.
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Search Alerts/Recalls
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