Recall Z-0271-2009 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Bionics Corp
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
| Date | Oct 31, 2008 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | 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 |
| Quantity | 6549 units |
| Distribution | Nationwide and Internationally - Ireland, Korea, Mexico, The Netherlands, United Kingdom, Canada, Australia and Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.