FDA-Device2013-03-06Class II
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Advanced Neuromodulation Systems Inc.
Hazard
Unintended Fluid ingress into the device header has been shown.
Sold states
Worldwide Distribution - 53 consignees out of the US.
Affected count
388 units
Manufactured in
6901 Preston Rd, N/A, Plano, TX, United States
Products
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0894-2013Don't want to check this manually?
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