Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Hazard
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
What You Should Do
Remedy
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.