Patient noted, that a current medication is causing repeated falling episodes.Medication is unrelated to the nalu system or the area being treated by the nalu system.Patient reported, an immediate loss of therapy after the nalu system was struck, during a fall.The system was functioning as expected, prior to the patient fall.It is likely, that the system was damaged by the fall.And that the failure is not related to any device deficiency.
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Patient was implanted, with the nalu peripheral nerve stimulator system on (b)(6) 2023.To treat shoulder pain.Patient was initially receiving pain relief from the system.In (b)(6) 2023, the patient reported, sustaining a fall on (b)(6) 2023.In which, the implantable pulse generator (ipg) was directly struck.The patient reported, an immediate loss of therapy after the fall.Troubleshooting was attempted and not successful.Xray imaging did not show any migration or damage to the implanted components.On (b)(6) 2024, the patient underwent surgical revision to replace the ipg and the implanted lead.During the revision, there was visual confirmation of damage to the silicone boot, connecting the lead to the ipg.As well as some damage noted, to the lead itself.The physician and the nalu representative present at the procedure noted, that the damage appears to be a result of the patient fall.
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