Company:St. Jude Medical, Inc..
Date of Enforcement Report 4/4/2018
Class lI:
PRODUCT
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Recall Number Z-1170-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Inc., Plano TX on 3/9/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17
DISTRIBUTION
Nationwide
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