The Q-TRAK Subcutaneous Electrode Adverse Events: FDA MAUDE Data
CAMERON HEALTH, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Sep 2012
Total Reports
212
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shocks from Noise Oversensing
noise, primary, sensing vector, inappropriate, vector
2
reports
Subcutaneous Implantable / Vector / Inappropriate
noise, shock, subcutaneous implantable, inappropriate, vector
2
reports
S-ICD Explanted and Replaced
subcutaneous, subcutaneous implantable, effects, electrode, additional adverse
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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