EMBLEM S ICD Adverse Events: FDA MAUDE Data
Oscor Inc. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
468
Reports (30d)
8
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shock Due to Non-Physiological Artifacts
primary, subcutaneous implantable, remains service, secondary, vector
2
reports
Inappropriate Shock from Noise Oversensing
noise, shock, services, sensing vector, vector
2
reports
High Impedance Measurements in Subcutaneous ICD
subcutaneous, subcutaneous implantable, impedance, ohms, electrode
1
reports
Inappropriate Shock Due to Noise Oversensing
subcutaneous, subcutaneous implantable, provided, data, inappropriate
1
reports
Inappropriate Shock Due to T-Wave Oversensing
icd delivered, subcutaneous, service additional, reported subcutaneous, subcutaneous implantable
1
reports
Technical Services Consult for S-ICD Issues
subcutaneous, subcutaneous implantable, technical services, services, vector
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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