Model Number DTMA1Q1 |
Device Problem
Pacing Problem (1439)
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Patient Problem
Dizziness (2194)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) the patient experienced dizziness. additionally, the patient reported slow rates and suspected pacing is not working. 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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Continuation of d10: 694265 lead implanted: (b)(6) 1999 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 dizziness was not related to a product performance issue and the suspicion of the crt-d pacing not working was not confirmed.
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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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