BEUDAMED
    FDA Enforcement Class II Terminated

    Proclaim DRG Implantable Pulse Generator, Model Number 3664

    Recall: Z-1170-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1170-2018
    Event ID
    79560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St. Jude Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    March 9, 2018
    Classification Date
    March 23, 2018
    Termination Date
    November 3, 2020
    Address
    6901 Preston Rd, Plano, TX, 75024-2508, United States

    Description

    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.

    Code Info

    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

    Distribution

    US

    Quantity

    17 units