MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2017 · 2 device variants grouped
Total Reports
4,007
Reports (30d)
30
Active Signals
2
Open Recalls
78
What the reports describe · Claripulse analysis
Inappropriate Therapy for Tachycardia
crt, atrial, therapy, tachycardia, ventricular tachycardia
21
reports
CRT Device Explanted Due to Infection
cardiac resynchronization, crt, infection, patient complications, result event
11
reports
Premature Battery Depletion Observed
resynchronization, cardiac resynchronization, battery, crt, resynchronization therapy
11
reports
Difficulty Interrogating CRT Device
resynchronization, defibrillator crt, crt, resynchronization therapy, therapy defibrillator
3
reports
Oversensing from Electromagnetic Interference
defibrillator crt, resynchronization, cardiac resynchronization, crt, resynchronization therapy
2
reports
CRT Explanted for Unspecified Reason
defibrillator crt, cardiac resynchronization, resynchronization therapy, therapy defibrillator, crt explanted
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
A novel method to enable biventricular defibrillator to biventricular pacemaker downgrade involving DF4 defibrillator lead.
Giedrimas A, et al. · 2018
Citations indexed from PubMed.
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