FDA-Device2020-07-15Class II

Patient Connector, Model Number 24967

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

Sold states
worldwide
Affected count
1025 devices
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Patient Connector, Model Number 24967

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2506-2020

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