Events

Recall of Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Bionics Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30494
  • Event Risk Class
    Class 3
  • Event Number
    Z-0396-05
  • Event Initiated Date
    2004-11-11
  • Event Date Posted
    2005-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36004
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Product Code LGW
  • Reason
    A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
  • Action
    Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.

Device

Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
  • Model / Serial
    All Codes
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • Manufacturer Address
    Advanced Bionics Corporation, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Source
    USFDA