MEDTRONIC EUROPE SARL COBALT¿ XT HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPA2D4 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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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 during use of the cardiac resynchronization therapy defibrillator (crt-d), the patient stated "was told by heart physician i been in atrial fibrillation (af) for forty days, and monitor showed seven days out of the forty days.I am concerned how active the device is in detecting." the patient was referred to the physician. the crt-d remains in use. no further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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