EMBLEM S ICD Adverse Events: FDA MAUDE Data
Oscor Inc. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
487
Reports (30d)
6
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
S-ICD Inappropriate Shock Due to Noise
subcutaneous, subcutaneous implantable, effects, inappropriate, vector
11
reports
ICD Explanted for Performance Anomaly
implantable cardioverter, subcutaneous, subcutaneous implantable, cardioverter defibrillator, defibrillator icd
1
reports
Inappropriate Shock Due to Noise Oversensing
noise, oversensing noise, shock, sensing vector, vector
1
reports
Shock Impedance Measurement Issues
impedance, shock impedance, services, ohms, electrode
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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