Abstract
Background: Complications using internal cardiac monitors are have been
reported at a low rate. Targeted analyses of complications have not been
well described. Objective: To investigate and describe complications
associated with internal cardiac monitor (ICM) events reported to the
FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
Methods: Our team reviewed all reported events for the Reveal LINQ loop
recorder submitted to the MAUDE database over seven years
(1/1/2013-12/31/2019). A 5% random selection of reports was audited by
two researchers to ensure report validity. Two cardiologists manually
reviewed death and incongruent events for final interpretation. Results:
12,652 records were obtained during the observed time period. A total of
15,587 device complications were reported. Of this, under-sensing (n =
4509, 28.93%), premature discharge of battery (n = 3262, 20.93%),
over-sensing (n = 2788, 17.89%), and other sensing issues (n = 1532,
9.83%) were most commonly reported. Patient adverse events were
reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site
infection (n = 213, 20.68%), erosion (n = 138, 13.40%), and impaired
healing (n = 49, 4.76%) were most commonly reported to affect patients.
Death was reported four times; after expert review, no reports justified
the device or procedure as a reasonable cause. Verification of events
reported 99.53% accuracy of reporting. Conclusion: Several
non-life-threatening ICM complications were commonly noted from the
analysis. This study supports the safe use of ICMs. A better
understanding of the complication profile will help providers select
patients, provide informed consent, and expected management.