Advanced Bionics Corp Recalls
Showing 1-4 of 4 recalls
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
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
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.
Precision Implantable Pulse Generator (IPG), Model Number SC-110
Mislabeled: Product labeled with the incorrect shelf-life information.
There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.
The Precision Implantable Pulse Generator, Model Number SC-1110
The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.
Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS CORP 12740 San Fernando Rd. Sylmar, CA 91342 USA. The Precision Spinal Cord Stimulator System (Precision 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
Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on
In the United States, notification will be sent to patients with the affected devices. Additionally, their physicians on record will be provided with the notification. The Company is currently planning to initiate this field action on September 22, 2008. The U.S. notification will be sent via Fed Ex or U.S. Postal Service certified mail. The letter advises that Boston Scientific Neuromodulation is voluntarily recalling its first generation charging device, Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System. The Charger 1.0 devices are being recalled and will be replaced with the new second generation Precision Charger 2.0 (SC-5312, currently in distribution) that features a temperature limiter for improved temperature management. The Charger 1.0 can be used until replacement with Charger 2.0 by following the instructions on Page 2 of the letter. Customers are asked to complete the acknowledgement form at the end of the letter and return it to Boston Scientific in the return envelope provided. A representative from Boston Scientific will contact them upon receiving the completed form to schedule an in-person visit at their physician's office to exchange the device. Contact Boston Scientific Technical Serives at (866) 566-8913 for assistance.