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 following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable 16-output, multi-channel stimulator (IPG - Implantable Pulse Generator) with a rechargeable battery power source. The IPG, commonly implanted in the abdomen or buttock area (less frequently in the subclavicular area), can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. An externally used Charger is utilized to transcutaneously recharge the IPG (Implantable Pulse Generator) battery. Currently, Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For improved heat management, Charger 2.0 is equipped with thermistor (temperature sensing component), designed to activate/deactivate charging at a set temperature.
Recall
- Recall Number
- Z-0271-2009
- Event Number
- 49525
- Firm
- Advanced Bionics Corp
- FEI Number
- 1000220815
- Product Code
- LGW
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 22, 2008
- Posted
- October 31, 2008
- Terminated
- January 24, 2012
- Address
- 25129 Rye Canyon Loop, Valencia, CA, 91355
Description
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 following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable 16-output, multi-channel stimulator (IPG - Implantable Pulse Generator) with a rechargeable battery power source. The IPG, commonly implanted in the abdomen or buttock area (less frequently in the subclavicular area), can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. An externally used Charger is utilized to transcutaneously recharge the IPG (Implantable Pulse Generator) battery. Currently, Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For improved heat management, Charger 2.0 is equipped with thermistor (temperature sensing component), designed to activate/deactivate charging at a set temperature.
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.
Nationwide and Internationally - Ireland, Korea, Mexico, The Netherlands, United Kingdom, Canada, Australia and Israel
6549 units