Model Number NIPG1500 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing records were reviewed and no relevant nonconformities were found.Nevro is awaiting the return of the device.
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Event Description
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It was reported to nevro that the patient had the device removed.Nevro attempted to obtain additional information regarding the nature of the device removal but none was available.There were no reports of device-related issues from the patient prior to the device removal.
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Manufacturer Narrative
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The device was returned and analyzed.Visual inspection of the returned device did not find any anomaly.Functional testing was performed and the device operated to specifications.Review of the patient's diagnostic data also showed no evidence of a device malfunction.The manufacturing records were reviewed and no non-conformities 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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