Model Number W1DR01 |
Device Problem
Pacing Problem (1439)
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Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
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Event Date 03/25/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the patient experienced heart rates in the forties on a home blood pressure device and hypotension.Heart rates in the sixties to one hundreds were noted by the emergency medical services and in the fifties and sixties in the emergency department.The implantable pulse generator (ipg) exhibited possible pacing below the lower rate and remains in use. no further patient complications have been reported as a result of this event.
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Event Description
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It was reported that the patient experienced heart rates in the forties on a home blood pressure device.Heart rates in the sixties to one hundreds were noted by the emergency medical services and in the fifties and sixties in the emergency department.The implantable pulse generator (ipg) exhibited possible pacing below the lower rate and remains in use. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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