FDA-Device2018-04-04Class II
Proclaim DRG Implantable Pulse Generator, Model Number 3664
St. Jude Medical, Inc.
Hazard
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Sold states
US
Affected count
17 units
Manufactured in
6901 Preston Rd, Plano, TX, United States
Products
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1170-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief