DYNAGEN X4 CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
943
Reports (30d)
10
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
High Out of Range Impedance Measurements
crt, lead, impedance, range, impedance measurements
5
reports
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, revision infection, crt explanted
5
reports
Far Field Oversensing on Right Atrial Lead
crt, remains service, resynchronization therapy, therapy defibrillator, oversensing
3
reports
Oversensed Signals Inhibiting Pacing
defibrillator crt, cardiac resynchronization, crt, therapy defibrillator, resynchronization therapy
1
reports
Battery Depletion Analysis Requested
battery, crt, effects, data, resynchronization therapy
1
reports
Unable to Interrogate Device
resynchronization, crt, remains service, resynchronization therapy, therapy defibrillator
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
Freedman RA, et al. · Pacing and clinical electrophysiology : PACE · 2009
Porter B, et al. · Frontiers in physiology · 2018
Kutyifa V, et al. · Heart rhythm · 2013
Citations indexed from PubMed.
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