Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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On (b)(6) 2024, additional information was received indicating that stroke was ruled out.The patient is at baseline and is able to speak again.This is considered a nonserious event as the patient is able to speak again (therefore, not a permanent impairment) and no intervention was provided.As such, this event has been reassessed as a non-mdr reportable patient event.Note: h6.Medical device problem code of "appropriate term/code not available (a27)" is representative of "patient event non-serious" manufacturer's ref.# (b)(4).
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