FDA-Device2017-10-25Class II
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
St. Jude Medical, Inc.
Hazard
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Sold states
Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
Affected count
3,119 devices
Manufactured in
6901 Preston Rd, Plano, TX, United States
Products
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2018Don't want to check this manually?
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