Model Number 429888 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problems
Chest Pain (1776); Dyspnea (1816)
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Event Date 11/21/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced dyspnea, occasional chest pain, and worsening heart failure. the left ventricular (lv) lead exhibited high impedance and a fracture.The patient has hospitalized as a result.The lv lead 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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Event Description
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Additional information received noted the patient was hospitalized again and medication was adjusted.It was noted that reprogramming was done to address the fracture and high impedance of the left ventricular (lv) lead.It was also noted that the proximal extremes of the lead were affected, and the distal extremes maintain integrity.The lead remains in use.
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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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