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St. Jude Medical, Inc. recalls Proclaim DRG Implantable Pulse Generator, Model Number 3664
Recalled April 4, 2018 · FDA recall Z-1170-2018 · St. Jude Medical
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. · FDA Class II
Units
17 units
Sold at
US
Description
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.
Product
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Manufacturer(s)
St. Jude Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →