ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD)
Total Reports
1,280
Reports (30d)
27
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Device Disconnected from Remote Monitoring
observed, reprogramming, event patient, stable, technical
27
reports
RV Lead Exhibited High Impedance
noise, programming, lead exhibited, stable, oversensing
5
reports
ICD Experienced Premature Battery Depletion
depletion, battery, icd explanted, explanted replaced, battery depletion
2
reports
ICD Explanted Due to Pocket Infection
infection, patient complications, pocket, icd explanted, result event
1
reports
Electrode Dislodged Causing Inappropriate Shock
noise, adverse, effects, electrode, additional adverse
1
reports
RV Lead Exhibited High Pacing Impedance
lead remains, pacing impedance, impedance, lead exhibited, use right
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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