The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.(b)(4).
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It was reported that operation of the external pulse generator (epg) was difficult, and the epg had issues gaining capture.Attempts were made to switch the epg with other epgs, with differing results of successful and unsuccessful operation.The cables were also switched in an attempt to troubleshoot; however, the same issues were experienced regardless of the epg or cables used.It was suspected that the issue was caused by competitor epicardial leads.The recommendation was made to have their biomedical engineering department test the epg and consider a return for analysis.The status of the epg is unknown.No patient complications have been reported as a result of this event.
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