MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA1Q1 |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: 429888 lead implanted: (b)(6) 2016 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 during use of the cardiac resynchronization therapy defibrillator (crt-d), atrial events appear to be falling in blanking at times possibly triggering atrial tachycardia (at)/atrial fibrillation (af) device classified termination of at/af detected events, and leading to intermittent inappropriate atrial pacing.The crt-d remains in use.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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