Sprint Quattro Secure S DXAC/DSP Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Jan 2019 · 2 device variants grouped
Total Reports
489
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Rising Defibrillation Impedance in RV Lead
lead remains, pacing impedance, impedance, lead exhibited, use right
4
reports
RV Lead Integrity Alert Triggered
integrity alert, lead integrity, alert lia, lia, integrity
3
reports
CRT Device Explanted for Infection
crt, infection, patient complications, patient experienced, result event
1
reports
ICD Explanted Due to Infection
implantable cardioverter, infection, event implantable, defibrillator icd, icd explanted
1
reports
Misclassified Episode Detection in RV Lead
oversensing twos, lead remains, wave oversensing, lead exhibited, twos
1
reports
Suspected Lead Fracture in RV Lead
suspected, lead explanted, fracture, voltage, low
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Zhang S, et al. · PloS one · 2015
Haq KT, et al. · The Journal of innovations in cardiac rhythm management · 2021
Akhtar M, et al. · Clinical Medicine Insights. Cardiology · 2014
Nicolis D, et al. · Journal of arrhythmia · 2022
Turning a blind eye to the far field: Are we burying the evidence? A case of abrupt catastrophic implantable cardioverter defibrillator lead failure causing sudden death.
Tuohy S, et al. · HeartRhythm case reports · 2015
Citations indexed from PubMed.
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