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)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shock from Oversensing Noise
subcutaneous, subcutaneous implantable, effects, inappropriate, vector
3
reports
ICD Anomaly Leading to Replacement
implantable cardioverter, subcutaneous, subcutaneous implantable, cardioverter defibrillator, defibrillator icd
1
reports
Inappropriate Shocks from Noise Oversensing
noise, oversensing noise, shock, sensing vector, vector
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Uehara Y, et al. · Heart rhythm O2 · 2025
O'Neill L, et al. · HeartRhythm case reports · 2022
Iacopino S, et al. · Pacing and clinical electrophysiology : PACE · 2024
Citations indexed from PubMed.
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