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Model Number LNQ11 |
Device Problems
Over-Sensing (1438); Under-Sensing (1661); Decreased Sensitivity (2534); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The overall baseline gender characteristics is female; the age of the patients was approximately (b)(6) years old.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.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.Referenced article: "accuracy of arrhythmia detection in implantable cardiac monitors: a prospective randomized clinical trial comparing reveal linq and confirm rx." pacing and clinical electrophysiology.2020 ;43:1344¿1350.Doi: 10.1111/pace.14076.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed that contained information regarding the accuracy of arrhythmia detection in implantable cardiac monitors (icm).The article reports false atrial fibrillation (af), brady, and pause detection in icms due to p-wave and t-wave oversensing (twos), oversensing of noise artifacts, and r-wave undersensing with r-wave amplitude variations.The status/ disposition of the devices is unknown.No patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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Search Alerts/Recalls
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