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 03/22/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: 5076-52 lead, implanted (b)(6) 2018.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 inappropriate high voltage therapy and inappropriate anti-tachycardia pacing for atrial fi brillation (af) with rapid ventricular response that the cardiac resynchronization therapy defibrillator (crt-d) 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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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 received inappropriate high voltage therapy for supra ventricular tachycardia (svt).
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Search Alerts/Recalls
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