Class 2 Device Recall Activa PC, Activa RC, Active SC

• Date Initiated by Firm: September 30, 2013
• Date Posted: November 14, 2013
• Recall Status: Terminated on November 20, 2015
• Recall Number: Z-0279-2014
• Recall Event ID: 66506
• PMA Number: P960009
• Product Classification: Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
• Product: Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Code Information: all serial numbers
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave NE; Minneapolis MN 55432-3568
• For Additional Information Contact: Technical Services; 800-707-0933
• Manufacturer Reason for Recall: Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).
• FDA Determined Cause: Software design
• Action: In September 2013 Medtronic issued a medical device correction letter titled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. Medtronic field representatives will be updating the model 8870 software application card to version AAR/01, which is contained in the physician programmer. A Physician Reply Form was asked to be signed and returned by fax or mail for acknowledging the receipt of the Urgent Medical Device Correction letter. When the Medtronic field rep updates the software application card of the physicains' programmer, they will complete a Rep Reply For: 8870 Card Update to AAR/01.
• Quantity in Commerce: 62,634
• Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
• 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 = MHY and Original Applicant = MEDTRONIC Inc.