MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA1QQ |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2024 |
Event Type
Injury
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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 during use the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy due to the device feature that uses pattern and rate analysis to discriminate between supraventricular tachycardia (svt) and true ventricular tachyarrhythmias. the crt-d 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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Additional information received indicated and clarified that the crt-d had two failed high voltage therapies for ventricular fibrillation (vf) episode, which is not a device malfunction but rather is due to patient condition, as the device functioned as intended by administering therapy.After, the patient¿s crt-d was interrogated, a new template for the patient¿s arrhythmic waveform designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of an supra ventricular tachycardia (svt) origin was created because the previous template was inconsistent with the patient¿s intrinsic rhythm.
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Manufacturer Narrative
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Device codes (fdd/annex a), additional codes: imf (annex f) health impact.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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