FDA-Device2017-10-25Class II
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
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
28,817 devices
Manufactured in
6901 Preston Rd, Plano, TX, United States
Products
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2018Don't want to check this manually?
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