FDA-Device2021-05-12Class II
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Sold states
Worldwide distribution.
Affected count
16,311 units
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1528-2021Don't want to check this manually?
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