Model Number DTMA1QQ |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 03/01/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: 479888 lead implanted: (b)(6) 2019; 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 cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy for atrial fibrillation (af) with rapid ventricular response detected as ventricular fibrillation (vf).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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It was further reported that the patient had a history of af with rapid ventricular response and an atrioventricular node ablation was performed to address the patient condition.
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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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Search Alerts/Recalls
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