Model Number NIPG2000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Urinary Retention (2119); Electric Shock (2554)
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Event Date 02/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing records were reviewed and no relevant nonconformities were found.
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Event Description
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It was reported to nevro that the patient experienced a shocking sensation and urinary incontinence.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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The device was returned and analyzed.The device works as expected and successfully completed all the tests performed during the investigation.No abnormality was found that could explain the reported condition.The manufacturing records were reviewed and no relevant nonconformities were found.
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Event Description
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The device was returned and analyzed.
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Search Alerts/Recalls
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