Home / Recalls / St. Jude Medical, Inc. / Z-1170-2018

Z-1170-2018 Class II Terminated

Recalled by St. Jude Medical, Inc. — Plano, TX

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
March 9, 2018
Termination Date
November 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

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.

Distribution Pattern

US

Code Information

Lot Number 6210849 Serial Number AVM174.1 Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1, AVK678.1, AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1 Lot Number 6278155 Serial Number AVK896.1

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