Recall Z-1170-2018— St. Jude Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by St. Jude Medical, Inc., initiated 2018-03-09, terminated 2020-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Proclaim DRG Implantable Pulse Generator, Model Number 3664. 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
- St. Jude Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-09
- Terminated
- 2020-11-03
- Firm location
- Plano, TX, United States
Product description
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.