ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024 · 5 device variants grouped
Total Reports
8,476
Reports (30d)
185
Active Signals
3
Open Recalls
2
What the reports describe · Claripulse analysis
Remote Transmission Revealed Oversensing
transmission revealed, remotely merlin, net review, review transmission, merlin net
64
reports
Remote Oversensing Post-Paced T-Wave
net, remotely merlin, implantable cardioverter, exhibited post, merlin net
52
reports
Remote Follow-Up Oversensing Observed
device technical, icd, observed device, remote follow, cardioverter
44
reports
Post-Paced T-Wave Oversensing
exhibited post, icd, defibrillator exhibited, wave oversensing, paced wave
29
reports
Remote Follow-Up Oversensing Episodes
follow episodes, remote follow, episodes post, oversensing pptwos, device technical
25
reports
Infection with Device Pocket Erosion
explanted, icd, infection, pocket, ventricular lead
21
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
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Evidence
Pre-infection cerebral cortex structure predicts murine sepsis outcome.
Gallant RM, et al. · 2025
Clinical field study evaluating the safety and efficacy of allogeneic uterine-derived mesenchymal stem cells for refractory feline chronic gingivostomatitis.
Williams VS, et al. · 2025
Does mental illness history affect primary care chronic disease management in older adults? A population-based propensity score-matched study.
Correia RH, et al. · 2025
Seeing the Whole Picture: Evaluating the Contribution of Whole Grains to Phosphorus Exposure in People With Kidney Failure Undergoing Dialysis Treatment.
Winkelman D, et al. · 2024
Establishing a role for the oral microbiome in infectious complications following major oral cavity cancer surgery.
Gallant JN, 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. 3 active signals detected right now.
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