|
Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
Erosion (1750)
|
Event Date 01/01/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The overall baseline gender characteristics is 50% female and 50% male; the baseline age of the patients was 39 years old.The baseline weight of the patients is 68 kgs.Please see attached excel file with specific patient/device codes.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿un-linqed: spontaneous extrusion of newer generation implantable loop recorders.¿ indian pacing and electrophysiology journal, https://doi.Org/10.1016/j.Ipej.2020.04.005.If information is provided in the future, a supplemental report will be issued.(b)(4).
|
|
Event Description
|
A journal article was reviewed which contained information regarding insertable cardiac monitors (icms).Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.The article reported that there were four patients whose icm spontaneously extruded within 7-24 days after insertion.Of note, there was no pain reported with any of the extrusions were reported to be pain free, and there were no device or pocket infections noted in any case.The status/location of the icm is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|