Viva Quad XT CRT-D Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Jul 2021 · 2 device variants grouped
Total Reports
797
Reports (30d)
0
Active Signals
0
Open Recalls
78
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Oversensing and Pacing Inhibition
defibrillator crt, crt, lead, use, high
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
Oomen AWGJ, et al. · Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2017
Magnetic field interactions of smartwatches and portable electronic devices with CIEDs – Did we open a Pandora’s box?
Patrick Badertscher, et al. · IJC Heart & Vasculature · 2022
The effect of stereotactic body radiotherapy (SBRT) using flattening filter‐free beams on cardiac implantable electronic devices (CIEDs) in clinical situations
Hossein Aslian, et al. · Journal of Applied Clinical Medical Physics · 2020
Citations indexed from PubMed.
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