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

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Τίτλος: Rapid early battery depletion and lead-electrode corrosion owing to CIED gate oxide semiconductor defects.
Συγγραφείς: Hauser RG; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota. Electronic address: rhauser747@gmail.com., Witt D; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota., Kapphahn-Bergs M; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota., Sengupta JD; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Πηγή: Heart rhythm [Heart Rhythm] 2026 Sep; Vol. 23 (9), pp. 1992-1999. Date of Electronic Publication: 2026 Feb 26.
Τύπος έκδοσης: Journal Article; Research Support, Non-U.S. Gov't
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Country of Publication: United States NLM ID: 101200317 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1556-3871 (Electronic) Linking ISSN: 15475271 NLM ISO Abbreviation: Heart Rhythm Subsets: MEDLINE
Imprint Name(s): Original Publication: New York, NY : Elsevier, c2004-
Ιατρικοί όροι (MeSH): Defibrillators, Implantable*/adverse effects , Pacemaker, Artificial*/adverse effects , Electrodes, Implanted*/adverse effects , Equipment Failure* , Electric Power Supplies* , Semiconductors*, Humans ; Corrosion ; Equipment Design ; Equipment Failure Analysis
Περίληψη: Background: 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.
Objective: 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.
Methods: 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.
Results: 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).
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.
(Copyright © 2026 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
Competing Interests: Disclosures The authors have no conflicts of interest to disclose.
Contributed Indexing: Keywords: Battery; Corrosion; Failure; Impedance; Lead; Premature; Reliability
Entry Date(s): Date Created: 20260227 Date Completed: 20260826 Latest Revision: 20260829
Update Code: 20260830
DOI: 10.1016/j.hrthm.2026.02.037
PMID: 41759871
Βάση Δεδομένων: MEDLINE
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  Data: Rapid early battery depletion and lead-electrode corrosion owing to CIED gate oxide semiconductor defects.
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  Data: <searchLink fieldCode="AU" term="%22Hauser+RG%22">Hauser RG</searchLink>; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota. Electronic address: rhauser747@gmail.com.<br /><searchLink fieldCode="AU" term="%22Witt+D%22">Witt D</searchLink>; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.<br /><searchLink fieldCode="AU" term="%22Kapphahn-Bergs+M%22">Kapphahn-Bergs M</searchLink>; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.<br /><searchLink fieldCode="AU" term="%22Sengupta+JD%22">Sengupta JD</searchLink>; Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
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  Data: <searchLink fieldCode="JN" term="%22101200317%22">Heart rhythm</searchLink> [Heart Rhythm] 2026 Sep; Vol. 23 (9), pp. 1992-1999. <i>Date of Electronic Publication: </i>2026 Feb 26.
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  Data: Journal Article; Research Support, Non-U.S. Gov't
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101200317 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1556-3871 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215475271%22">15475271 </searchLink><i>NLM ISO Abbreviation: </i>Heart Rhythm <i>Subsets: </i>MEDLINE
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  Data: <i>Original Publication</i>: New York, NY : Elsevier, c2004-
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  Data: <searchLink fieldCode="MM" term="%22Defibrillators%2C+Implantable%22">Defibrillators, Implantable*</searchLink>/<searchLink fieldCode="MM" term="%22Defibrillators%2C+Implantable+adverse+effects%22">adverse effects</searchLink> <br /><searchLink fieldCode="MM" term="%22Pacemaker%2C+Artificial%22">Pacemaker, Artificial*</searchLink>/<searchLink fieldCode="MM" term="%22Pacemaker%2C+Artificial+adverse+effects%22">adverse effects</searchLink> <br /><searchLink fieldCode="MM" term="%22Electrodes%2C+Implanted%22">Electrodes, Implanted*</searchLink>/<searchLink fieldCode="MM" term="%22Electrodes%2C+Implanted+adverse+effects%22">adverse effects</searchLink> <br /><searchLink fieldCode="MM" term="%22Equipment+Failure%22">Equipment Failure*</searchLink> <br /><searchLink fieldCode="MM" term="%22Electric+Power+Supplies%22">Electric Power Supplies*</searchLink> <br /><searchLink fieldCode="MM" term="%22Semiconductors%22">Semiconductors*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Corrosion%22">Corrosion</searchLink> ; <searchLink fieldCode="MH" term="%22Equipment+Design%22">Equipment Design</searchLink> ; <searchLink fieldCode="MH" term="%22Equipment+Failure+Analysis%22">Equipment Failure Analysis</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: 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.<br />Objective: 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.<br />Methods: 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.<br />Results: 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).<br />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.<br /> (Copyright © 2026 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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  Data: Disclosures The authors have no conflicts of interest to disclose.
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  Data: <i>Keywords: </i>Battery; Corrosion; Failure; Impedance; Lead; Premature; Reliability
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        Value: 10.1016/j.hrthm.2026.02.037
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        Text: English
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        StartPage: 1992
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        Type: general
      – SubjectFull: Corrosion
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      – SubjectFull: Equipment Design
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      – SubjectFull: Equipment Failure Analysis
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      – SubjectFull: Electric Power Supplies
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      – SubjectFull: Semiconductors
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      – TitleFull: Rapid early battery depletion and lead-electrode corrosion owing to CIED gate oxide semiconductor defects.
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