Model Number TLEAD1058-70B |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/05/2019 |
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 to nevro that during the trial procedure the insertion needle sheared off the most distal electrode of the lead into the patient.No injuries were sustained by the patient and the lead was replaced without further incident; however the electrode remains in the patient.Follow-up indicated that the patient had a successful trial and the physician is planning to remove the detached electrode during the implant procedure.There have been no reports of further complications regarding this event.
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Manufacturer Narrative
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The lead was returned for analysis.The most distal electrode and the lead body at the tip were missing.The conductor wires were exposed and high magnification imaging showed the wire strands were necked and fractured.An insertion needle likely dragged across the surface of the lead during lead withdrawal, which led to the needle catching onto the distal electrode and resulting in fracture of the device.
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Event Description
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The lead was removed and returned for analysis.Follow-up indicated that the detached electrode was removed during the implant procedure as planned.
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Search Alerts/Recalls
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