Model Number 429888 |
Device Problems
Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2024 |
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 atrial (ra) lead dislodged and no longer was sensing or pacing. the ra lead was scheduled for revision and, was explanted and replaced. during the ra lead revision procedure, on fluoroscopy the physician noticed the left ventricular (lv) lead was slightly pulled back and only the lv1 pole was in the branch, the rest were in the coronary sinus. it was confirmed that lv2,3 and 4 had high thresholds. the lv was explanted and replaced. no patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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