BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
300
Reports (30d)
3
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
High Out-of-Range Shock Impedance Measurements
measurements, crt, shock, impedance, range
2
reports
Loss of Capture on Ventricular Leads
capture, defibrillator crt, crt, effects, therapy defibrillator
1
reports
Noise and Oversensing on Atrial Channel
defibrillator crt, crt, effects, service, therapy defibrillator
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 7, 2022 · Open, Classified
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Evidence
Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study.
Sardu C, et al. · 2016
ECG-Capable Smartwatches Can Induce Magnet Mode in Cardiac Implantable Electronic Devices.
Wegner FK, et al. · 2025
Premature end of service of implantable cardioverter-defibrillator by magnetic interference with left-ventricular assist device.
Eiringhaus J, et al. · 2021
Suboptimal biventricular pacing. What is the mechanism?
Tan VH, et al. · 2019
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. 1 active signal detected right now.
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