Model Number 459888 |
Device Problems
Failure to Capture (1081); High impedance (1291); Stretched (1601)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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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 during the implant procedure, the physician went to slit the coronary sinus catheter and inner guide and the inner guide catheter was kinked and became more kinked when slitting was attempted.Upon trying to remove the catheter, the left ventricular (lv) lead was "stretched".The lead was tested and impedances were consistently high and was failing to capture.The lead was removed and a new lead was successfully implanted.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.No anomalies were found.The distal low voltage electrode of the lead was covered in body t issue/fibrotic growth.The analyst noted there were no anomalies observed regarding the returned lead.All electrical testing was within specified parameters.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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