Due to limited information and the absence if any unique identifiers, no investigation can be conducted.Regarding the statement about the software/firmware error, there have been 2 field actions initiated, both have been reported to the fda per 21 cfr part 806.Reference fda recal numbers z -1192-2016 through z-1194-2016 and z -1600-2016.Due to issues with the portal set up process, this mdr has not been submitted.Nuvectra is actively working with the esg helpdesk at the fda (ticket #s (b)(4)).Device not returned to manufacturer.
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A report was received through the fda's medwatch program (mw5064075).The report was forwarded to nuvectra and received by nuvectra on (b)(6) 2016.The report states, "the lead used with algovita scs device made by nuvectra broke apart and fragments remain in the pt's body.Happened twice on 2 different leads.Also, there is a software/formware error in algovita scs that may result in catastrophic failure of implanted device known to company but perhaps not reported.".
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