It was reported that, for several days after the ventricular assist device (vad) implant procedure, the patient experienced epistaxis where the "blood just kept coming." the patient's anticoagulation medication was held, they had an ablation procedure and they received blood transfusions.The vad remains in use. no further patient complications have been reported as a result of this event.
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Investigation of this event is pending and a supplemental report will be sent upon its completion.On of this event is pending and a supplemental report will be sepon its completion.Continuation of d10: 6947m62 lead implanted (b)(6) 2014### 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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