MEDTRONIC SINGAPORE OPERATIONS SPRINT QUATTRO SECURE S MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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Model Number 6935M62 |
Device Problems
Failure to Capture (1081); 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 02/28/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient had presented to the emergency department post shock and was noted to have high atrial threshold.There was a query for micro dislodgment. a lead revision and reprogramming was performed and various positions attempted and high threshold continued. the right ventricular (rv) lead was queried for micro dislodgment , exhibited an increase in threshold and had loss of capture.A chest x-ray indicted that the lead had no slack compared to day one chest x-ray.Diagnostic testing and troubleshooting were performed.The ra lead remains in use and the rv lead was explanted and replaced. no 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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Product event summary: the full lead was returned and analyzed.Returned product analysis was performed and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.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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