Model Number NEU_ENTERRA_INS |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.[mw5073411.Pdf].
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Event Description
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The healthcare provider (hcp) reported via the user facility that the device explanted and revised due to a dysfunctional implant.The patient outcome was hospitalization.There were no further complications reported as a result of this event.
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Search Alerts/Recalls
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