MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number A2DR01 |
Device Problem
Pacing Problem (1439)
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Patient Problems
Arrhythmia (1721); Bradycardia (1751); Nausea (1970)
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Event Date 04/11/2024 |
Event Type
malfunction
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Event Description
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It was reported that the implantable pulse generator (ipg) was functioning below the programmed rate and as a result the patient exp erienced bradycardia, with palpitations, nausea, stinging sensation over left chest palpitations occur.The device 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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