Model Number DTMA1QQ |
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 02/17/2024 |
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) detected as ventricular fibrillation (vf).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 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) detected as ventricular fibrillation (vf).The patient had not felt well since.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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Additional information received indicated the patient was not seen and/or remote transmission received.Three days following the high voltage therapy the patient called to tell the facility/healthcare professional that a shock was received.Labs were ordered for the patient.The patient refused emergency room.
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Search Alerts/Recalls
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