DYNAGEN CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared Apr 2014 · 3 device variants grouped
Total Reports
876
Reports (30d)
3
Active Signals
0
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
4
reports
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
3
reports
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
3
reports
System Explanted Due to Pocket Infection
crt, infection, patient complications, pocket, result event
1
reports
Intermittent Loss of Capture on LV Lead
crt, remains service, effects, loss capture, capture
1
reports
Inappropriate Anti-Tachycardia Pacing Delivery
crt, tachycardia, anti, delivered, atp
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
De Ruvo E, et al. · Pacing and clinical electrophysiology : PACE · 2010
Cardiac implantable device interrogation in left ventricular systolic dysfunction reveals physiologic abnormalities prior to symptom onset in COVID-19: a case series
Matthew S. Delfiner, et al. · European Heart Journal - Case Reports · 2022
Caravati F, et al. · Clinical case reports · 2020
Citations indexed from PubMed.
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