Sprint Quattro Secure Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Apr 2017 · 2 device variants grouped
Total Reports
4,909
Reports (30d)
7
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
T-Wave Oversensing on Right Ventricular Lead
oversensing twos, wave oversensing, use, use right, twos
16
reports
High Impedance Warning on Defibrillation Coil
triggered, coil, defibrillation, use, use right
13
reports
Lead Integrity Alert Triggered by Noise
triggered, non, alert, use, integrity
13
reports
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
9
reports
High Thresholds on Right Ventricular Lead
high capture, stable condition, thresholds, exhibited high, use right
5
reports
Undersensing on Right Ventricular Lead
episode, undersensing, observed right, use, use right
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead.
Hauser RG, et al. · Heart rhythm · 2007
Defibrillation failure with an electrical short circuit caused by internal insulation breach
Takuo Tsurugi, et al. · HeartRhythm Case Reports · 2021
Citations indexed from PubMed.
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