Model Number TLEAD1058-50B |
Device Problems
Material Separation (1562); 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 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis of the returned device is currently in progress.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 during the implant procedure, the physician found detached electrodes from trial leads left behind in the epidural space.The trialing physician had noted no issues when the trial leads were removed.The implanting physician has removed all but one electrode and currently has no plans to retrieve the remaining electrode.The procedure was completed without further complications and the patient is currently using their device with effective pain relief.
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Manufacturer Narrative
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The lead fragment was returned and analyzed.Visual inspection of the returned device showed a scratch, and flattened contacts.Diagnostic data showed all lead impedances of contacts were functional and within normal range for the whole trial period.Based on patient data and the reported information the lead was fractured and damaged during the removal of the leads.The patient anatomy anomaly was a contributor factor that mostly likely caused resistance and difficulty during removal of the leads.The manufacturing records were reviewed and no non-conformities were found.
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Event Description
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The device was returned and analyzed.
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Search Alerts/Recalls
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