Model Number DTPA2QQ |
Device Problems
Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
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Patient Problem
Tachycardia (2095)
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Event Date 03/09/2024 |
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 cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy for true ventricular tachycardia (vt) which was classified as supra ventricular tachycardia (svt) via the device feature that compares the patient's current qrs waveform to a collected and stored template of the patient's qrs waveform during sinus rhythm.The device is still in use.It was also reported that the remote monitoring network report contained invalid data.Diagnostic interpretation was provided.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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Additional information received noted reprogramming was done, and the device remains in use.
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Search Alerts/Recalls
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