Amplia MRI Quad CRT-D SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2017 · 2 device variants grouped
Total Reports
1,827
Reports (30d)
8
Active Signals
1
Open Recalls
78
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion
resynchronization, defibrillator crt, battery, crt, therapy defibrillator
4
reports
RV Lead Oversensing and Pacing Inhibition
defibrillator crt, crt, lead, use, high
3
reports
Inappropriate Therapy for Atrial Tachycardia
crt, patient complications, tachycardia, ventricular tachycardia, result event
2
reports
Patient Reports Issues Post-Implant
result event, defibrillator crt, cardiac, crt, patient complications
2
reports
Explanted Due to ERI with Battery Issues
battery, additional information, resolve event, patient stable, explanted
1
reports
RA Lead Undersensing During Atrial Events
fibrillation, atrial, lead, atrial fibrillation, tachycardia
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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
Giannotti A, et al. · APL bioengineering · 2023
Ozcan C, et al. · Heart rhythm · 2011
Bhargava K, et al. · Indian heart journal · 2016
Bhargava K, et al. · Indian pacing and electrophysiology journal · 2016
Montgomery JA, et al. · Pacing and clinical electrophysiology : PACE · 2019
Citations indexed from PubMed.
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