BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
2,154
Reports (30d)
63
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Inappropriate Therapy Delivered for Atrial Rhythm
crt, remains service, therapy, tachycardia, delivered
18
reports
High Out-of-Range Shock Impedance Measurements
measurements, crt, shock, impedance, range
18
reports
CRT Revision Due to Infection
crt, crt revision, infection additional, reported crt, revision infection
15
reports
Battery Voltage Low, Data Analysis Requested
crt, battery, effects, data, voltage
9
reports
CRT Revision for Infection
crt revision, infection additional, reported crt, revision infection, crt explanted
8
reports
Noise and Oversensing on Atrial Channel
defibrillator crt, crt, effects, service, therapy defibrillator
8
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
Impact of wideband phase-sensitive inversion recovery motion corrected late gadolinium imaging on 3T cardiac magnetic resonance image quality and diagnostic utility in patients with cardiac implantable electronic devices.
Black C, et al. · 2025
Citations indexed from PubMed.
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