Model Number DTPA2QQ |
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 Type
Injury
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Event Description
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It was reported that the patient experienced inappropriate therapy by the cardiac resynchronization therapy defibrillator (crt-d). the device remains in use. the patient is a participant in a clinical study.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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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 crt-d delivered an inappropriate shock for atrial fibrillation (af)/atrial flutter detected as ventricular fibrillation (vf).
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Search Alerts/Recalls
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