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BACKGROUND Reports on the subcutaneous implantable cardioverter defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices. OBJECTIVE To describe and analyze S-ICD complications reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS We reviewed all S-ICD MAUDE reports submitted over 24 months (2/16-2/18) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service. RESULTS After removing duplicate entries and non-clinical events (n=493), 1604 events remained. There were 542 instances of infection with system removal reported in 414 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) of patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow up (n=2), VF induced by the device (n=4), device-device interaction resulting in undersensing (n=1), procedure related complications (n=4), and uncertain etiology (n=4). There were 137 reports of system migration, and in 57 (42%) of these there were associated inappropriate shocks. System migrations events were managed with a combination of system revision (69, 51%), reprogramming (25, 18%), and system removal (44, 32%). CONCLUSION Several S-ICD complications have been reported that appear to be related to the ICD's design and function over time. A better understanding of these complications may help inform patient selection, implant technique, and post-implant management.