Events

Recall of Precision Implantable Pulse Generators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Bionics Corp.

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
    45853
  • Event Risk Class
    Class 2
  • Event Number
    Z-0960-2008
  • Event Initiated Date
    2007-10-05
  • Event Date Posted
    2008-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66266
  • 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
    Implanted spinal-cord stimulator for pain relief - Product Code LGW
  • Reason
    Incorrect data -- corruption of internal memory component results in an inability for the physician to reprogram the ipg with firmware version prior to revision 3.02. when this occurs, the ipg will report an error code of "10h0" or "00h0" through the remote control. under this condition, the ipg will cease to log in some data that could be used for informational purposes. ** it should be noted t.
  • Action
    Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices. The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry. If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.

Device

Precision Implantable Pulse Generators
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
  • Product Description
    Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
  • Manufacturer
    Advanced Bionics Corp

Manufacturer

Advanced Bionics Corp
  • Manufacturer Address
    Advanced Bionics Corp, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Source
    USFDA