Model Number DTMB1D4 |
Device Problems
Pacing Problem (1439); 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 03/28/2024 |
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.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 patient received possible inappropriate anti-tachycardia pacing and defibrillation therapy for an episode o f supra ventricular tachycardia (svt) that the cardiac resynchronization therapy defibrillator (crt-d) classified as ventricular fibrillation (vf).An atrial tachycardia/atrial fibrillation (at/af) episode was in progress during therapy.The device remains 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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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 further reported that the patient was seen or followed remotely.The therapy was confirmed to be appropriate.No action was taken.
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Search Alerts/Recalls
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