MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA2QQ |
Device Problem
Pacing Problem (1439)
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Patient Problem
Syncope/Fainting (4411)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 6935m62, serial# (b)(6), implanted: (b)(6) 2023.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 right ventricular (rv) lead exhibited oversensing two months prior and was subsequently reprogrammed to tip to coil sensing and the sensitivity was adjusted.The patient now presented with syncope.A remote transmission from the previous month was reviewed by qualified personnel in which it was suspected that the patient's rhythm was faster than the adaptive setting for auto post ventricular atrial refractory period (pvarp) adjustment which may temporarily not be able to keep up.The rv and cardiac resynchronization therapy defibrillator (crt-d) remain 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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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.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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