Important Medical Device Safety Information - 2nd Notice

Last month I received a letter in the mail from St. Jude Medical.  After reading it I discarded it thinking that it had nothing to do with me. 

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.

We have notified the regulatory authorities, including the U.S. Food and Drug Administration, of this action.

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!

speech disorder or a late talker?

Recently Leo and I had a chat abot Lucas.  We know he still has a long way to go with his speech but we are very proud parents lately!  Lucas tries so hard to talk.  He is patient and will repeat himself so that we can figure out what he is saying.  He will try to repeat anything we ask from him.  He also loves to mimick everything his big brother says.  When we look at his progress we use the past year as a yardstick.  Last year at this time (26months old) he began calling me "Mommy" it is a memory I will always cherish.  We are still about a year behind in his speech development but we can't look at what he isn't able to do, we have to focus on his abilities.  While talking to a friend this past week it dawned on me that many people do not understand what it means when we say Lucas to has a speech disorder.  Could it be that one day it will just click for him and he will talk? 

Many people think that it is normal for a child to not talk till 3 years old.  This could be true in some cases.  There are many factors that are involved in regards to when a child learns to speak.  If a child lacks motivation to speak because a parent or sibling does all the talking for them.  If a child is being raised bilingual then it could take their brain a little longer to aclimate to both languages.  If a child has fluid in their ears they could need tubes put in and then suddenly they become fluent talkers.  A baby who was born prematurely can hit their milestones late.  Children develop at their own rate and boys tend to develop later than girls. 

How do we know Lucas has a speech disorder and is not simply a late talker?  Great question.  It helps to know where he should be on the speech milestones compared to what he is currently able to do.  Also, I think the best way to answer this is to explain the extent we have gone through to give him help to learn to speak.  As most parents await their babies first babbled words of "Mama, Dada, and Baba" the babble usually happens around 7-9 months and by 12 months old you will have those sweet real first words.  Of course they will not be able to be completely understood and they will mostly be single word syllables.  Just like when your little one took their first wobbly steps it wasn't long after that they became a runner.  The same goes with speech, between 12 months and the first spoken words and when they turn 2 years old their vocabulary and speech just take off running!  By 2 years old your baby is able to speak in two to three word sentences. 

So where does Lucas compare?  When Lucas was 18 months old Leo and I had heard a few babbled Mama, Dada and Baba's - let me clarify this, I would hear him say Mama twice a month while he was watching tv or staring out the window.  By the time he was 20 months old we still hadn't made much progress in his speech.  By 22 months old I was officially worried so we called for Early Intervention to come in and evaluate him.  We began services the month before he turned 2 years old.  Lucas qualified for 2 one hour sessions of developmental therapy and 1 one hour session of speech therapy.  It was at 26 months old (3 months of therapy) when Lucas first came running in to see me and he said Mommy!  I held him tight and when he went running out of the room I turned into my pillow and cried happy tears.  Progress has been slow and steady.  We are finally at two and three word sentences.  We continue to struggle with clarity but as long as you can use context or a visual cue you can figure out what he is saying.  During a short visit at his school I was watching from the hallway and I heard Lucas tell his teacher "Daddy Tractor" however after he repeated himself 3 times the teacher still didn't get what he was saying so I did what any obsessive mother would do, I did a loud whisper translating what he said!  Lucas has also picked up a stutter during the last few months.  This also hurts the clarity of what he is trying to say.  I know we have a long road ahead of us but I trust that we are moving in the right direction so I just need to have patience. 


I have learned a lot about how difficult it is to produce speech.  You have to know how to move your jaw, tongue, lips all the muscles in your mouth at the same time as using your voice.  I was always impressed when watching our EI SLP (early intervention speech language pathologist) work with Lucas.  She would take a seemingly simple word "UP" and patiently work with Lucas, sometimes touching his mouth and reminding him to "bump the lips".
Up.  Seems like an easy word doesn't it?   For Lucas this word has proven a challenge.  It took a few months before he was able to say it and then one day last fall he lost it.  What do I mean when I say he lost it?  Lucas had went from saying "UP" to saying "Fufp".  I would work with him to correct it and by the third try he was able to say it clearly again but if he tried it on his own he simply could not say this word.  There are days he says it perfectly and others that he needs some extra help. 

Sign language, facial cue's, PROMPT, Kauffman Cards, and using either context or visual cues have become our way of life.  Lucas loved his therapy sessions.  It became a family event to help Lucas learn to speak.  Remember our earlier question?  "How do we know Lucas has a speech disorder and is not simply a late talker?"  It is a great question because I think you can see the amount of effort we have put forward into his learning to speak.  That it is also more than just about speech production.  Lucas tries so hard to speak that it is often frusterating for him when we do not understand what he is saying.  He is a typical toddler "terrible two's" and "troublesome three's" but when you combine that with his innability to effectively communicate his needs then you can get a glorious toddler meltdown. 

How much should a three year old be able to say?  Between the ages of 3 and 4 years old your child should be able to speak 250-500 words, be able to produce sentences with 5-6 words, and speak clearly.  I find it so amazing to see how quickly a small baby can grow and learn. 

So what should a parent do if their 18month old is not babbling yet? Maybe he says Dada and Mama a few times a month but when he uses those words they are about the abstract objects and not about Daddy and Mommy. What if your 3 year old is talking but you worry about the extent of his vocabulary and clarity?  Talk to your pediatrician, talk to your childs school and call your local Early Intervention center.  They will probably ask you to have a hearing screening completed.  Trust your gut, you know your child the best and the professionals will evaluate.  If your child's speech is delayed then congratulate yourself on getting them the help they need instead of waiting.