INOGEN 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
1,151
Reports (30d)
5
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
5
reports
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
3
reports
Inappropriate Anti-Tachycardia Pacing Delivery
crt, tachycardia, anti, delivered, atp
2
reports
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
1
reports
Inappropriate Shock Delivery
icd, implantable cardioverter, cardioverter, cardioverter defibrillator, inappropriate
1
reports
Device Unable to be Interrogated
defibrillator crt, crt, remains service, effects, technical services
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
Citations indexed from PubMed.
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