Model Number LEAD1058-90B |
Device Problems
Component Missing (2306); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/07/2019 |
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 that during a lead revision, x-rays showed one electrode had detached from the lead and was left in the epidural space.The physician removed the lead and confirmed there was a missing electrode.The physician was not concerned about the detached electrode and did not plan to remove it.The lead was replaced and there have been no reports of further complications regarding this event.The patient is currently using the device to find effective therapy.
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Manufacturer Narrative
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The device was returned for analysis.Visual inspection found the first electrode was missing from the distal end.Review of the diagnostic data showed the electrode was functional at the time of implant but during the course of the implant period the impedance fluctuated and eventually showed open prior to the revision procedure.High-magnification revealed consistent necking and fracture of each individual conductor wire.The root cause of the failure was undetermined but was likely due to a large flexural strain.
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Search Alerts/Recalls
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