Date sent to the fda: 10/20/2017.(b)(4).To date the device has not been returned.If the device or further details are received at the later date, a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date, a supplemental medwatch will be sent.Does the surgeon believe that there was any deficiency in the temporary pacing wire? does the surgeon believe the myocardial infarction was related to the temporary pacing device? was there a failure to sense or failure to capture or both? were these cases previously reported?.
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