ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2023 · 5 device variants grouped
Total Reports
3,882
Reports (30d)
94
Active Signals
3
Open Recalls
4
What the reports describe · Claripulse analysis
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, intervention, cardioverter defibrillator, defibrillator icd
27
reports
Infection with Device Pocket Erosion
explanted, icd, infection, pocket, ventricular lead
21
reports
Remote Transmission Revealed Oversensing
transmission revealed, remotely merlin, net review, review transmission, merlin net
19
reports
MRI Mode Not Engaged After Imaging
support contacted, resolve event, technical support, mri, mode
16
reports
Patient Device Telemetry Loss
implantable cardioverter, loss, defibrillator exhibited, patient implantable, telemetry
14
reports
ICD Set Screw Failure During Implant
implant procedure, implantable cardioverter, icd, cardioverter defibrillator, defibrillator icd
12
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. 3 active signals detected right now.
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