D10 concomitant product: unk-bravo, unknown bravo, (sn: unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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According to the reporter, after the capsule was placed, the patient noticed that the recorder was flashing red.It was put in the chest and it paired.But it seemed to go in and out of connecting or pairing to the capsule.The study had 96 hours duration.There was no patient or user harm.
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