FDA-Device2021-07-28Class II
Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
Sold states
Worldwide Distribution
Affected count
666210 devices
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
Medtronic Reveal LINQ LNQ11 / PA96000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2021Don't want to check this manually?
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