ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD), Permanent Defibrillator Electrode (Lead) · First cleared May 1996 · 35 device variants grouped
Total Reports
19,619
Reports (30d)
222
Active Signals
13
Open Recalls
4
Detection
Regulatory
Aug 16, 2023 · Open, Classified
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Mar 10, 2022 · Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Mar 10, 2022 · Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Mar 10, 2022 · Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Evidence
Sudden and Fatal Malfunction of a Durata Defibrillator Lead due to External Insulation Failure.
Shah AD, et al. · 2015
Defibrillation failure with short ICD charge time: Internal short circuit of a Durata lead.
Okada A, et al. · 2019
[ISMETT experience with long-term left ventricular assist devices].
Nuzzi V, et al. · 2025
Electrical Storm Induced by Cardiac Resynchronization: Efficacy of the Multipoint Pacing Stimulation.
Gonella A, et al. · 2024
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 13 active signals detected right now.
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