Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revisio

FDA device recall Z-0960-2008 · posted 2008-02-27 · Terminated

Recall details

Recalling firm

Advanced Bionics Corp

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

LGW

Quantity affected

over 12,000 units

Distribution

Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.

Date initiated

2007-10-05

Date posted

2008-02-27

Date terminated

2012-02-29

Location

Sylmar, CA