Important Product Information
St. Jude Medical, an Abbott company, recently provided doctors and patients with information regarding a medical device advisory that a small number of patients have had a loss of therapy during surgical procedures due to interactions with other surgical equipment. Should you require a future surgery, a solution to improve your device’s protection called “Surgery Mode” is now available in a software upgrade and should be enabled prior to any future surgery.
If you have a Proclaim™ Elite IPG (Models: 3660 and 3662) or an Infinity™ IPG (Models: 6660, 6661, 6662 and 6663) implanted before June 2, 2017 the new “Surgery Mode” software feature is now available on your iPod‡ Patient Controller. Follow the instructions below on how to download the software upgrade and where to get further information.
How to upgrade your software
It is important for you to understand that your device is functioning normally. If you plan to have a surgery please ensure the below steps are followed prior to your surgery. An Abbott Support number has been set up to assist you with these steps at 1-888-397-8828 (U.S.).
- Install updated software
Please download the available software upgrade. After the update completes, you will see a Notification screen that describes “Surgery Mode”.
- How to activate Surgery Mode
In order to activate the “Surgery Mode” feature, a one-time connection to a Clinician Programmer is needed at your next checkup. Please schedule an appointment for follow-up if you plan on having a surgical procedure, or ensure this update is completed prior to that procedure. The Abbott Support number can assist you with these steps at 1-888-397-8828 (U.S.)
- Prior to a procedure
Follow the Instructions For Use for “Surgery Mode” prior to a surgical procedure by downloading the Infinity™ DBS System (244kb) or Proclaim™ SCS Neurostimulation System (931kb) brochures. Instructions can also be found at manuals.sjm.com.
Advisory Patient FAQ (21kb)
Important Medical Device Advisory: Proclaim™ Elite SCS and Infinity™ DBS Neurostimulation Systems (35kb)
Infinity™ DBS System: Surgery Mode for Procedures (244kb)
Proclaim™ Neurostimulation System: Surgery and MRI Mode for Procedures and Scans (931kb)
Find more specific safety and use information for implantable pulse generators (IPG)
If you have any questions, please contact your Abbott Support at 1-888-397-8828 (U.S.). We sincerely apologize for any difficulties this current issue causes you or your caregivers. We take this matter very seriously. Please know that we are available to assist you if you are having problems with your device.