Model Number MC1AVR1 |
Device Problems
Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/12/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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).No 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.
|
|
Event Description
|
It was reported that during implant of the leadless implantable pulse generator (ipg), the delivery system deflection button was difficult to control and when removed, it moved poorly and was determined to be unusable.The leadless ipg was attempted/not used and replaced.During implant, the new leadless ipg became loose after the tether was cut and was removed with a snare.The implant procedure was discontinued. no patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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.
|
|
Search Alerts/Recalls
|
|