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

ABSTRACT

BACKGROUND: 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. OBJECTIVE: To investigate and describe complications associated with 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 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. RESULTS: 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. 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.