DYNAGEN X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared Apr 2014 · 2 device variants grouped
Total Reports
1,256
Reports (30d)
12
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
High Out of Range Shock Impedance Alert
measurements, crt, lead, impedance, range
7
reports
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
7
reports
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
6
reports
Device Unable to be Interrogated
defibrillator crt, crt, remains service, effects, technical services
2
reports
RV Lead Oversensing and Pacing Inhibition
defibrillator crt, crt, lead, use, high
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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
Related research
Perioperative Sensor and Algorithm Programming in Patients with Implanted ICDs and Pacemakers for Cardiac Resynchronization Therapy.
Niedermeier A, et al. · Sensors (Basel, Switzerland) · 2021
Boriani G, et al. · Journal of medical Internet research · 2013
Zile MR, et al. · ESC heart failure · 2020
Sekiguchi Y, et al. · Circulation journal : official journal of the Japanese Circulation Society · 2011
Citations indexed from PubMed.
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