Events

Recall of Device Recall Eon Mini Neurostimulation (IPG) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Neuromodulation Systems 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
    61151
  • Event Risk Class
    Class 2
  • Event Number
    Z-1983-2012
  • Event Initiated Date
    2011-12-19
  • Event Date Posted
    2012-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107420
  • 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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Reason
    The firm has received 112 complaints of the eon mini ipgs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. the firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin.
  • Action
    St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, customers should contact their St. Jude Medical Representative. If device replacement is required due to IPG failure related to this voluntary recall notice, St. Jude Medical will provide a replacement IPG at no charge. For questions regarding this recall call 972-309-2154.

Device

Device Recall Eon Mini Neurostimulation (IPG) System
  • Model / Serial
    Model Number 3788. All lots manufactured prior to September 20, 2010.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Eon Mini Neurostimulation (IPG) System (Model 3788); || The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
  • Manufacturer
    Advanced Neuromodulation Systems Inc.

Manufacturer

Advanced Neuromodulation Systems Inc.
  • Manufacturer Address
    Advanced Neuromodulation Systems 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