ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018 · 8 device variants grouped
Total Reports
10,450
Reports (30d)
52
Active Signals
3
Open Recalls
2
What the reports describe · Claripulse analysis
Remote Follow-Up Oversensing Observed
device technical, icd, observed device, remote follow, cardioverter
17
reports
Remote Oversensing Post-Paced T-Wave
net, remotely merlin, implantable cardioverter, exhibited post, merlin net
12
reports
Post-Paced T-Wave Oversensing
exhibited post, icd, defibrillator exhibited, wave oversensing, paced wave
11
reports
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, intervention, cardioverter defibrillator, defibrillator icd
10
reports
MRI Mode Not Engaged After Imaging
support contacted, resolve event, technical support, mri, mode
7
reports
Remote Transmission Revealed Oversensing
transmission revealed, remotely merlin, net review, merlin net, presented remotely
7
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
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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