On May 11th I received a 2nd Notice from St. Jude Medical. I retyped the letter below for you to read.
Important Medical Device Safety Information
Eon Mini Charging System
April 9,2013
Dear Patient,
You are receiving this letter as a follow-up to the Important Medical Device Safety Information letter you received from St. Jude Medical in July 2012 regarding potential for warmth or heating at the implant site during charging of Eon Mini spinal cord stimulators. We would like to inform you that a replacement charger, which has been redesigned to address this concern, is now available. Please call to schedule an in-person meeting with one of our presentatives to exchange your current charger Model 3721 for a newly redesigned Model 3722 charger. Please have your charger with you when you call. The new charger will be provided to you at no cost.
As you know, the Charging System is used to charge your spinal cord stimulator for the management of your chronic pain. St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients where using the previous Charging System to charge their spinal cord stimulator. A small number of these resulted in burns at the implant site. As a result, some physicians or patients in the past have requested explant surgery to address uncomfortable temperature elevations. St. Jude Medical will be exchanging patient chargers for the new Eon Mini Charger Model 3722 to reduce the potential for excess heating and explant surgery for this reason. Your physician is also being informed of the availability of the new charger and will receive a copy of the letter sent to you.
Identification of Chargers Eligible for Exchange: Current chargers which are eligible for exchange will have "Model 3721" printed in black letters in the lower left-hand corner of the white label on the back of the charger. This marking is showen in Diagram 1 below.
When selecting a time and place to receive your new charger, the St. Jude Medical representative will request that you attempt to charge your device using the new charger. It is possible that some patients with an Eon Mini spinal cord stimulator may not be able to successfully charge their device with the new charger. During the in-person meeting with our representative, a check will be done to confirm that the new replacement charger is effective in charging your Eon Mini spinal cord stimulator. Therefore, you will need to bring your current Eon Mini charger(s) and the charging antenna(s) with you to this meeting. If it is determined during the check that the new charger cannt be used, the representative will request that you continue using your current charger and ask you to consult with your physician to discuss the best options for you. If the new charger successfully charges your device, you will receive the new charger in exchange for your current charger.
The new Eon Mini LE Charging System, Model 3722 automatically cycles the energy it delivers to minimize the rise in temperature at the implant site during charging. As a result of this change, the new Model 3722 charger will take longer to fully recharge your spinal cord stimulator. For example, if you currently charge once per week for 30 minutes, it will take approximately 1 hour to charge with the new Eon Mini LE Charger. You can reduce the amount of charging time required at one time by recharging more frequently. While the new charger is designed to address the issue of excess heating during charging, it is normal to feel some warmth at the implant site or charging wand, but you should not feel discomfort or pain.
Until such time that you have received a replacement charger, please continue to follow the supplemental directions for use from the July 2012 letter. These directions are intended to lower the likelihood of excess heating with useof your current charger but may not eliminate this concern. Those supplemental instrustions are as follows:
- If the temperature at the implant site becomes uncomfortable during charging:
- Stop charging until the discomfort subsides and then resume charging;
- Reposition the charging antenna over the implant site;
- Consider recharging more frequently for less time;
- If the temperature continues to be uncomfortable, please contact your physician, SJM representative, or St. Jude Medical Technical Services.
- Avoid tightly inserting the charging wand between the body and a surface that may trap heat, such as a bed or chair.
- Use of topical anesthetics, medicated balm, and/or pain relief patches on the implant site prior to or during charging is not recommended, as it may reduce the ability to perceive heat or warmth near or at the implant site.
- Do not charge the device while asleep.
- Do not consume alcohol immediately prior to or while charging.
St. Jude Medical is dedicated to making the exchange of your charging system easy for you and we regret any inconvenience to you or your family. If you have any questions or concerns throughout this process, please call St. Jude Medical.
Sincerely,
Mark Neal
Vice President, Quality
Neuromodulation Division
St. Jude Medical
The phone call didn't take long. It lasted 12 minutes and that included a small wait and my questions. I was given a refrence number and informed that a representative will contact me in 2-3 weeks to set up an appointment for the exchange.
I am asking for prayers that the new Eon Mini LE Charger will successfully charge my device so that I will not need yet another surgery to replace my battery. I know that if I do end up needing another surgery it will only be for the battery (small surgery and short recovery). I also know that I have a great support system of family and friends to help me get through whatever lays ahead for me. However, I have had it with surgeries and I am counting on your prayers so that I can go at least another 9 years without surgery! That is my ultimate goal, 10 years between surgeries. Personally I feel like my 7 surgeries in the past 14 years (not counting my c-sections) is exsessive by any standard. Spinal Cord Stimulation has been a wonderful way to manage my chronic pain of RSD but it has it's downfalls. The definition of insanity = Doing the same thing over and over again expecting different results. It would be insanity for me to continue having Spinal Cord Stimulator surgeries every couple of years expecting that this one will be the one to last a decade. Thankfully we are only talking about a possible need to replace the battery. I hope that before I need another SCS revision we will have found a better treatment program for my RSD. Right now all I can do is keep moving forward. I cannot worry about IF because I need to focus on now. So, right now I have to wait a few weeks until I can meet with the representative from St Jude Medical and test the new Eon Mini LE Charger. If the connection cannot be made I will address that issue at that time. Until then, your prayers are needed to help prevent the "IF" from happening!
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