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

Abstract

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

Recall devices: Defects at initial visit and during remote monitoring supported follow‐up

“…Some other studies showed a lower percentage of premature battery depletion. Our observations are more similar to a study by Montgomery, who noted 2.3% of cases of premature battery depletion in a group of 838 ICDs and CRT‐Ds 4 . Similar outcomes were reported by Kumar in a RM group in a registry concerning the Abbott Premature Battery Depletion advisory 5 .…”

“…Our observations are more similar to a study by Montgomery, who noted 2.3% of cases of premature battery depletion in a group of 838 ICDs and CRT-Ds. 4 Similar outcomes were reported by Kumar in a RM group in a registry concerning the Abbott Premature Battery Depletion advisory. 5 In turn, Schwartz noted only three (1.5%) cases of premature battery depletion in a group of 196 ICDs.…”

Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients

“…The underlying cause of PBD in S-ICD systems investigated in this analysis shares similarities with those previously identified in TV-ICD, including low-voltage capacitor failure and lithium cluster disposition. 21 , 22 Malfunctioning of a low-voltage capacitor leads to release of small amounts of hydrogen within the system, which in turn leads to battery depletion. This can be detected through technical evaluation of explanted devices.…”

Evidence to support magnetic resonance conditional labelling of all pacemaker and defibrillator leads in patients with cardiac implantable electronic devices

“…This has occurred in 2.3% of patients with similar generator models unrelated to MRI. 26 This registry also included patients not recruited to other large registries due to abandoned leads, subcutaneous arrays, permanent epicardial leads, deactivated CIEDs, and CIEDs implanted before 2001. 6 , 7 Implantable cardioverter-defibrillators implanted before 2001 have demonstrated higher risk of MRI, 13 and this is consistent with the observation of symptomatic arrhythmia in one patient with a deactivated ICD implanted in 1999.…”