ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024
Total Reports
309
Reports (30d)
10
Active Signals
2
Open Recalls
2
What the reports describe · Claripulse analysis
Remote Follow-Up Oversensing Episodes
follow episodes, remote follow, episodes post, oversensing pptwos, device technical
5
reports
Lead Connection Failure During Implant
replaced, event patient, resolve event, explanted replaced, implant procedure
4
reports
Episodes of Post-Paced T-Wave Oversensing
observed device, wave oversensing, episodes post, paced wave, post paced
4
reports
Remote Oversensing Post-Paced T-Wave
implantable cardioverter, exhibited post, transmission, patient implantable, presented remotely
3
reports
Oversensing Observed, No Intervention
observed device, resolve event, stable condition, performed time, technical support
2
reports
ICD in Backup Mode After MRI
mode, icd, cardioverter, cardioverter defibrillator, mri
2
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
Catheter Ablation for Supraventricular Tachyarrhythmias in Adults With Total Cavopulmonary Connection Fontan Palliation.
Kamp AN, et al. · 2026
Catheter Ablation for Persistent Atrial Fibrillation: Rationale, Evidence, and Contemporary Strategies Beyond Pulmonary Veins.
Ruscio E, et al. · 2026
Atrial fibrillation: from pathogenesis to novel treatment options.
Liu Y, et al. · 2025
The fate of the Fontan circulation.
Barracano R, et al. · 2026
Comment on "Supraventricular Tachycardia Ablation in the Elderly-Characteristics and Outcomes".
Roman U, et al. · 2026
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. 2 active signals detected right now.
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