Accelerated Implantable Defibrillator Battery Depletion Secondary to Lithium Cluster Formation: A Case Series

Aggarwal, Ashim; Sarmiento, Joseph J.; Charles, R D O David; Parr, R B S Alan; Baman, Timir S.

doi:10.1111/pace.12808

Cited by 7 publications

(5 citation statements)

References 7 publications

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“…This was classified by the FDA as a class 1 recall 11 days later. The presence of lithium clusters can create a short circuit capable of causing rapid battery depletion to an end‐of‐service state over the course of days, contrasting with the low‐voltage capacitor malfunction that is typically detected with more than 4 weeks of device longevity remaining . In September 2017, Abbott unveiled a Battery Performance Alert (BPA) algorithm in the Merlin.net™ PCN and Merlin™ PCS programmer systems for their CRT‐Ds and ICDs under advisory .…”

Section: Discussionmentioning

confidence: 99%

Premature battery depletion due to compromised low‐voltage capacitor in a family of defibrillators

Montgomery

Sensing²,

Saunders³

et al. 2019

Pacing Clinical Electrophis

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Background: Boston Scientific (Marlborough, MA, USA) implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between 2008 and 2014 are potentially subject to premature battery depletion through a low-voltage capacitor malfunction occurring as a result of hydrogen buildup within the device. Although some of these devices are currently under advisory, other devices manufactured during this timeframe carry a lower risk of the same malfunction. These same devices are known to have superior longevity in general, and the overall mean lifespan of the devices remains long.Methods: All patients implanted or followed at our two centers who experienced premature battery depletion and had a Boston Scientific ICD or CRT-D potentially at risk for low-voltage capacitor malfunction were studied retrospectively.Results: Nineteen out of 838 patients (2.3%) with devices potentially at risk have had premature battery depletion: 5.7% of those under advisory and 1.1% of those not under advisory. None of our patients had compromised therapy, and all had >27 days of projected battery longevity remaining. Conclusions:Undetected premature battery depletion in this population of ICDs has the potential to expose a patient to an interval of time where the device is unable to provide therapy. However, with enrollment in remote monitoring, regular follow-up, and attention to audible alerts, the risk of therapy loss due to low-voltage state can be effectively mitigated. For these reasons, prophylactic generator replacement is not recommended. K E Y W O R D Sbattery failure, generator change, high-voltage capacitor, implantable cardioverter-defibrillator, low-voltage capacitor, premature battery depletion

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Section: Discussionmentioning

confidence: 99%

Premature battery depletion due to compromised low‐voltage capacitor in a family of defibrillators

Montgomery

Sensing²,

Saunders³

et al. 2019

Pacing Clinical Electrophis

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“…It is interesting to note that this phenomenon so far seems to be limited to the Unify/Fortify family of St. Jude Medical devices. Aggarwal et al identified two contributing factors: (1) the shape and orientation of the battery in the Unify/Fortify devices, (2) the higher energy output of the Unify/ Fortify (40 J) over the Ellipse (36 J) devices [3]. The electrical current can pass through the lithium cluster, generating a short circuit that causes overheating and damage to the battery cells, leading to rapid battery energy depletion [2].…”

Section: Discussionmentioning

confidence: 99%

“…At the time, the reported prevalence of this battery failure mechanism was approximately 0.004%. Aggarwal et al reported another four cases in 2016, and pointed out that the estimated prevalence of 0.004% was an underestimation [2,3]. Based on October 2016 data from St. Jude Medical, 841 (0.21%) out of 398,740 Unify/Fortify devices sold globally had been returned to the manufacturer because of early battery depletion, and they presented evidence of lithium material in the form of clusters in the battery.…”

Section: Discussionmentioning

confidence: 99%

A case of unexpected early battery depletion caused by lithium cluster formation in implantable cardioverter-defibrillator

Hayashi

Takagi

Kakihara

et al. 2017

Journal of Cardiology Cases

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“…An affected device may transit from the first trigger of the early replacement indicator to end‐of‐life within 24 hours, giving little time for the patient and the device to raise alarm and healthcare professionals to react . Premature battery depletion can result in abrupt loss of potentially life‐saving CIED functions and has been associated with patients’ death …”

Section: Factors Affecting Device Longevitymentioning

confidence: 99%

“…63 Premature battery depletion can result in abrupt loss of potentially life-saving CIED functions and has been associated with patients' death. [64][65][66]…”

Section: Premature Battery Depletionmentioning

confidence: 99%

Technologies for Prolonging Cardiac Implantable Electronic Device Longevity

Lau

2017

Pacing Clinical Electrophis

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Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.

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Accelerated Implantable Defibrillator Battery Depletion Secondary to Lithium Cluster Formation: A Case Series

Abstract: Clinicians must be aware of this occult cause of device failure and more studies are needed to determine its true prevalence.

Cited by 7 publications

References 7 publications

Premature battery depletion due to compromised low‐voltage capacitor in a family of defibrillators

Premature battery depletion due to compromised low‐voltage capacitor in a family of defibrillators

A case of unexpected early battery depletion caused by lithium cluster formation in implantable cardioverter-defibrillator

Technologies for Prolonging Cardiac Implantable Electronic Device Longevity

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