Adverse events of subcutaneous loop recorders: Insights from the MAUDE database

Complications using internal cardiac monitors (ICM) have been reported at a low rate. Targeted analyses of complications have not been well described in the literature.

To investigate and describe complications associated with ICM events reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over 7 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.

12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, undersensing (n = 4509, 28.93%), premature discharge of battery (n = 3262, 20.93%), oversensing (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.

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.