Rapid early battery depletion and lead-electrode corrosion owing to CIED gate oxide semiconductor defects

Cardiac implantable electronic devices (CIEDs) rely on metal-oxide-semiconductor gating transistors to control pacing pulse delivery. Gate oxide (GO) defects can produce high leakage currents that compromise battery longevity, electronic circuit function, and lead-electrode integrity.

This study aimed to assess manufacturers' reports of CIED GO failures, characterizing their presentation, timing, clinical impact, and findings from engineering analyses of explanted devices.

We searched the Food and Drug Administration's publicly available Manufacturer and User Facility Device Experience database for reports containing the terms "gate oxide" or "oxide" submitted by Abbott, Biotronik, Boston Scientific, and Medtronic.

We identified 178 GO failures reported for Boston Scientific devices (2011-2025) and 30 for Medtronic devices (2009-2021); none were reported for Abbott or Biotronik. The median time to failure was 5.8 months (interquartile range [IQR] 2.9-11.6). Pacemakers failed earlier (median 4.7 months; IQR 2.8-8.5) than implantable cardioverter-defibrillators (10.0 months; IQR 5.6-18.8). Presenting findings included premature battery depletion (n = 83), safety mode activation (n = 45), low lead impedance (n = 57), loss of telemetry (n = 25), and high power consumption (n = 21). Engineering analyses identified lead-electrode corrosion in 10 explanted leads, with electrical discontinuity in 4. Major adverse events included death (n = 2), cardiac arrest/asystole/shock (n = 5), syncope (n = 7), and heart failure (n = 6).

GO defects represent an early, manufacturing-related semiconductor failure mechanism in CIEDs that can rapidly deplete batteries, disable lifesaving therapy, and contribute to lead-electrode corrosion. Early recognition of characteristic device and clinical patterns may facilitate risk mitigation, particularly in vulnerable patients.