Class 2 Device Recall Bionic NAVIGATOR Clinician Programmer Model Number SC71504

• Date Initiated by Firm: March 19, 2010
• Date Posted: April 16, 2010
• Recall Status: Terminated on February 29, 2012
• Recall Number: Z-1409-2010
• Recall Event ID: 55190
• PMA Number: P030017
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Code Information: SERIAL #'s: 27059297H, 46080743H, 46080918H, 56066331H, 56069528H, 56069671H, 56069673H, 56069686H, 56072440H, 56072655H, 56072666H, 56072674H, 57014750H, 57014755H, 57014757H, 66084643H, 77048447H, 87040459H, 87040630H, 87040942H, 87040947H, 87040951H, 87040957H, 87042729H, 87042732H, 87043106H, 87043119H, 87058615H 87058616H, 87058618H, 87058849H, 87059667H, 87082650H, 87082900H, 87086049H, 87094579H, 87094580H, 87094590H, 87094593H, 87094596H, 87094597H, 87094738H, 96026241Hu, 96026251Hu, 97045074H, 97047825H, 97072474H, 97076337H, 97076339H, 97076666H, 97076671H, 97076770H, 97079617H, 97081025H, 97081842H, X6090220H, X6098238H, X6099082H, X7021190H, X7087236H, Z7014824H, Z7060102H
• Recalling Firm/ Manufacturer: Boston Scientific Neuromodulation Corporation; 25155 Rye Canyon Loop; Valencia CA 91355-5004
• For Additional Information Contact: 661-949-4000
• Manufacturer Reason for Recall: Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.
• FDA Determined Cause: Other
• Action: In a letter dated March 19, 2010 Boston Scientific informed consignees that it determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers, and telling them that they may be in possession of an affected product. They were advised that a Boston Scientific representative will contact them to arrange for an inspection of the Clinician Programmer (SC-7150-4). Until they have determined if the battery pack is affected, consignees were told they can only use their Toshiba portable computer with the original AC adapter power cord supplied with that computer, and were asked to remove the battery pack until its status is determined. Included with the letter was a Reply Verification Tracking Form which consignees were asked to complete the form following the instructions on the form and return to Boston Scientific in the enclosed postage paid return envelope or fax it to (877) 856-3546 by March 31, 2010. If they experience any issues they were told to cease using the Clinician Programmer and contact Boston Scientific's 24-hour Patient Care Hotline at (866) 360-4747. Customers can also contact the Field Action team by phone at (866) 684-7504 or by fax at (877) 856-3546 if they had any questions.
• Quantity in Commerce: 62 units
• Distribution: Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WI Internationally: Italy
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LGW and Original Applicant = Boston Scientific Corp.