(b)(4).As the device was not returned, an analysis investigation could not be performed. a conclusion could not be reached as to what may have caused or contributed to the event. the lot was not provided; therefore, the manufacturing records evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the exact implant date? what is the lot number for the linx device? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
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