Model Number MC1AVR1 |
Device Problems
Mechanical Problem (1384); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that during the implant the leadless implantable pulse generator (ipg) was not able to be recaptured for repositioning.It was noted that tissue was blocking the recapture.The leadless implantable pulse generator (ipg) and the delivery system were attempted/not used and replaced.A new leadless ipg was then implanted successfully however there was difficulty noted when the delivery system was flushed during preparation prior to implant.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This is a system report.The section d information is for the primary device, which was in use with the following: brand name [micra] product id [mc1avr1-delsys] (serial: (b)(6).D9: no medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary:the full delivery system was returned and analyzed.The lumen of the delivery system was torn.There was a mec hanical issue with the tether of the delivery system.The delivery system tether was frayed.The delivery system outer shaft was kinked/buckled.The delivery system inner shaft was mechanically kinked/bent.The analyst noted the full delivery system was returned w ith the device intact with the tether but not fully recaptured in the device cup.The deployment button was locked in the recaptured position of the delivery system handle upon receipt.The tether was between the device and device cup upon receipt.The inner shaft was kinked inside of the delivery system handle.The outer shaft was kink/buckled at the distal end of the stability member of the delivery system.Deployment testing could not be performed as the inner shaft was kinked inside of the delivery system handle negating deployment of the device.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 device was returned and analyzed.There was an issue observed with the electrode.The device electrode was found with damage causing the device to fail functional testing.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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