MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number W4TR01 |
Device Problem
Pacing Problem (1439)
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Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
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Event Date 04/05/2024 |
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.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 one day post implant, the patient presented to the emergency department with hypotension and bradycardia with a heart rate in the thirties, which was below the programmed lower rate.It was noted that the percentage of effective device pacing had declined prior to the bradycardia.The cardiac resynchronization therapy pacemaker (crt-p) remains in use.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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