Advanced Bionics Corp.

Reports per year

Source: FDA adverse event reports by year received, 1996–2009. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Implant, CochlearMCM2,175
• Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW817
• Stimulator, Spinal-Cord, Implanted (Pain Relief)GZB81
• Product code ------1
• Permanent Pacemaker ElectrodeDTB1
• Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1

Recent recalls

• 2008-10-31TerminatedOther

  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

• 2008-02-27TerminatedDevice Design

  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

• 2008-02-27TerminatedDevice Design

  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 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

• 2007-10-12TerminatedError in labeling

  Precision Implantable Pulse Generator (IPG), Model Number SC-110

  Mislabeled: Product labeled with the incorrect shelf-life information.

• 2007-03-31TerminatedOther

  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.