Model Number 6947M62 |
Device Problems
Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 02/28/2024 |
Event Type
Injury
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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 the right ventricular (rv) lead had undersensing, oversensing noise, and a lead integrity alert (lia).The patient had received an inappropriate shock from the lead and the lead was suspected to have a low voltage fracture.The lead was explanted and replaced.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Initial aware date (b)(6) 2024.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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