Model Number 694865 |
Device Problem
Failure to Capture (1081)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Event Description
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It was reported that a nurse visualized loss of capture on telemetry monitoring.The right atrial (ra) and right ventricular (rv) leads remain in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: ddmb1d1 icd 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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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 through a follow-up investigation, that there was no issue with loss of capture on the leads.
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Search Alerts/Recalls
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