Model Number TLEAD1058-70B |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Nevro is awaiting the return of the device.The manufacturing records were reviewed and no non-conformities were found.
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Event Description
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It was reported to nevro that during the implant procedure the cap on the stylet broke off.The physician was able to remove the stylet without incident.No injuries were sustained by the patient.The procedure was completed with no further reports of complications and the patient is currently receiving effective pain relief from the device.
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Manufacturer Narrative
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Follow-up indicated that the device was lost and will not be returned.The physician suspected that he had pressed too hard while using the stylet.The manufacturing records were reviewed and no non-conformities were found.
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Search Alerts/Recalls
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