Arrhythmias & electrophysiologyCohort study
Rapid early battery depletion and lead–electrode corrosion owing to CIED gate oxide semiconductor defects
- Analysis of manufacturers' reports in the Food and Drug Administration's publicly available Manufacturer and User Facility Device Experience database
Authors' conclusion
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.
Study context
- Population
- Cardiac implantable electronic devices (CIEDs) with gate oxide (GO) failures reported by Abbott, Biotronik, Boston Scientific, and MedtronicGO failure reports · Boston Scientific devices (2011-2025) 178 · Medtronic devices (2009-2021) 30
- Exposure
- Pacemakers vs implantable cardioverter-defibrillators
Main finding
As reported in the abstract
GO failures reported for Abbott or Biotronik
- none were reported for Abbott or Biotronik
Observational data: associations, not effects.
Further findings
Time to failure
- Time to failure — Median time to failure, all
- 5.8 months (interquartile range [IQR] 2.9-11.6)
- Time to failure: Pacemakers failed earlier than implantable cardioverter-defibrillators
Presenting findings
- premature battery depletion
- n = 83
- safety mode activation
- n = 45
- low lead impedance
- n = 57
- loss of telemetry
- n = 25
- high power consumption
- n = 21
Engineering analyses of explanted leads
- lead-electrode corrosion in explanted leads
- 10
- electrical discontinuity, of the 10 corroded leads
- 4
Safety
Major adverse events
- death
- n = 2
- cardiac arrest/asystole/shock
- n = 5
- syncope
- n = 7
- heart failure
- n = 6
Original publication
Rapid early battery depletion and lead–electrode corrosion owing to CIED gate oxide semiconductor defects. Heart Rhythm. Published 26 February 2026. doi:10.1016/j.hrthm.2026.02.037
Summarised from the published abstract; every number is checked against it