Model Number DTPA2QQ |
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 03/06/2024 |
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.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 therapy and high voltage therapy for atrial fibrillation (af) with rapid ventricular response that the cardiac resynchronization therapy defibrillator (crt-d) classified as ventricular fibrillation (vf).The crt-d remains in use.There was also occasional undersensing noted on the right atrial (ra) lead and an increase in thresholds on the left ventricular (lv) lead since implant.Both leads remain 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 it was confirmed that the therapy was inappropriate.The patient's medication was adjusted and reprogramming was performed.
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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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Search Alerts/Recalls
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