Events

Recall of Device Recall Proclaim DRG Implantable Pulse Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1170-2018
  • Event Initiated Date
    2018-03-09
  • Event Date Posted
    2018-03-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162647
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable pulse generator, programmer and battery charger - Product Code PMP
  • 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.
  • Action
    Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.

Device

Device Recall Proclaim DRG Implantable Pulse Generator
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US
  • Product Description
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • Manufacturer Address
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA