Key result
Pacemaker Safety Mode accounts for ~83% of major adverse events vs. Back-up or Reset modes.
Why the study?
Boston Scientific reported that its pacemaker Safety Mode could pause pacing or cause inhibition and life-threatening outcomes, prompting evaluation of associated adverse events compared with other manufacturers backup modes.
Is Boston Scientific's Safety Mode associated with more major adverse events compared to Abbott's Back-up and Medtronic's Reset modes?
Observational (n=2,059)
Is Boston Scientific's Safety Mode associated with more major adverse events compared to Abbott's Back-up and Medtronic's Reset modes?
Boston Scientific's Safety Mode is associated with significantly more major adverse events, including syncope and pacing inhibition, compared to backup modes from other manufacturers, suggesting it may be unsafe for pacemaker-dependent patients.
Answers are grounded in this paper and cite their sources.
Safety Mode was associated with most major adverse events; leaves open optimal mode selection for pacemaker-dependent patients pending prospective data.
Background In 2021, Boston Scientific (BSC) announced its Ingenio pacemakers (PM) could exhibit high battery impedances (HBI) and trigger the Safety Mode (SM) that should preserve pacing when PM function is jeopardized. SM is VVI or BiV, 72.5ppm, and sensitivity is unipolar autogain 0.25mV. In 2023, BSC said SM may pause pacing ~ 20 seconds and 3 deaths occurred in pacemaker-dependent patients. In 2024 BSC warned some Accolade PMs had HBI and SM could cause inhibition and life-threatening outcomes. Objective To quantitate adverse events (AE) associated with SM and compare them to Abbott's Back-up (BU) and Medtronic's Reset (RE) modes. Methods The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database was searched from 2014-2024 for AE involving SM, BU, and RE (SBR). Major AE included asystole, cardiac arrest, syncope, heart failure, and falls. Results We found 2,059 SBR AE, including 6 deaths and 648 major AE; 537 (82.9%) of the major AE were pacemakers in SM vs 80 (12.3%) in BU and 31 (4.8%) in RE (p < 0.001). SM was associated with 354 syncopal events that resulted in head injuries (n=24) or falls (n=26); 71 BU+RE syncopal events resulted in 2 head injuries and 2 falls (p<0.001). Pacing inhibition or oversensing was described for 204 (57.6%) SM syncopal events but none for BU or RE. HBI was the most common but not exclusive cause of SM. Conclusion SM is associated with major AEs that are more numerous and serious than BU or RE. Most SM AEs appear related to its high sensitivity and consequently SM may be unsafe for pacemaker-dependent patients.
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Bahbah et al. (2025) conducted an observational in Pacemaker adverse events (n=2,059). Boston Scientific Safety Mode (SM) vs. Abbott's Back-up (BU) and Medtronic's Reset (RE) modes was evaluated on Major adverse events (asystole, cardiac arrest, syncope, heart failure, and falls) (p=<0.001). Boston Scientific's Safety Mode accounted for 82.9% of 648 major adverse events, more than Abbott's Back-up and Medtronic's Reset modes.
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