Events

Recall of Device Recall Eon Mini

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

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
    63108
  • Event Risk Class
    Class 2
  • Event Number
    Z-1836-2013
  • Event Initiated Date
    2012-07-26
  • Event Date Posted
    2013-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112563
  • 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
    As part of st. jude medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 eon mini ipgs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. explant surgery, as with any surgery, presents a risk to patient health. adverse events associated with an unplanne.
  • Action
    St. Jude Medical sent a Important Medical Device Recall Advisory dated July 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To further assist in your patient care we are providing you with a list of all serial numbers we show have been distributed to you. ( See Attachment A ). Further questions please call (972) 309-2154.

Device

Device Recall Eon Mini
  • Model / Serial
    Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Product Description
    Eon Mini - 3788 (IPG), || Eon Mini system 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
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Address
    St. Jude Medical, 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