Model Number NIPG1500 |
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 04/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing records were reviewed and no issues were found.
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Event Description
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It was reported to nevro that the patient's device was removed likely due to silicone allergy.Nevro attempted to obtain a medical assessment but was unavailable and there have been no reports of further complications regarding this event.
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Manufacturer Narrative
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The system was explanted and returned for analysis.Visual inspection of the returned devices did not find any anomaly.Functional testing was performed and the devices 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 nonconformities were found.
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Search Alerts/Recalls
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