ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD)
Total Reports
195
Reports (30d)
0
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Inappropriate ATP and Shocks Delivered
tachycardia pacing, tachycardia, delivered, anti tachycardia, atp
1
reports
Inappropriate ATP for Ventricular Tachycardia
fibrillation, patient complications, complications, tachycardia, ventricular tachycardia
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Novel findings of an old algorithm: PVC response "Atrial Pace'' initiates atrial arrhythmias in Abbott ICD and CRT-D devices.
Sane M, et al. · Pacing and Clinical Electrophysiology · 2022
Beyond the stethoscope: managing ambulatory heart failure during the COVID-19 pandemic.
Oseran AS, et al. · 2021
Contemporary benefit-harm profile over two decades in primary prophylactic ICD-therapy.
Kleemann T, et al. · 2019
Tailoring cardiac resynchronisation therapy to non-left bundle branch block: Successful cardiac resynchronisation for right bundle branch block with left posterior fascicular block without implantation of a left ventricular lead.
Dennis MJ, et al. · 2022
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.
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