Events

Recall of Device Recall Brio DBS 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
    61554
  • Event Risk Class
    Class 2
  • Event Number
    Z-0894-2013
  • Event Initiated Date
    2012-03-28
  • Event Date Posted
    2013-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108418
  • 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, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • Reason
    Unintended fluid ingress into the device header has been shown.
  • Action
    St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication. For questions regarding this recall call 972-309-2154.

Device

Device Recall Brio DBS System
  • Model / Serial
    Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - 53 consignees out of the US.
  • Product Description
    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
  • 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