Medtronic DBS Recall, Article #2

May 19, 2013 By Leave a Comment
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Another article found on the Medtronic DBS recall.
Source: Nuero News,

Medtronic announces FDA Class I recall of deep brain stimulation lead cap
Friday, 03 May 2013 15:33

Medtronic has issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits. The US Food and Drug Administration (FDA) has classified the communication as a Class I Recall.

Medtronic, according to a company release, has received reports of deep brain stimulation leads being damaged due to twisting of the connector within the lead cap during the surgical procedure. The lead cap is included in deep brain stimulation lead kits and dystonia therapy kits and is sometimes used temporarily to protect the end of a deep brain stimulation lead after it has been implanted. The deep brain stimulation lead cap is not used in all deep brain stimulation procedures, and is not permanently implanted. Depending on the extent of lead damage due to twisting of the connector during the placement and removal of the lead cap, lead replacement may be required or optimal therapy may not be achieved.

In the case of lead damage, Medtronic advised, if at the beginning of therapy patients are receiving therapy as expected, they are not likely to be affected by this issue. Patients with questions relating to this issue are encouraged to talk with their physicians.

A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use deep brain stimulation lead caps.

Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, and the FDA’s MedWatch Program at www.fda.gov/MedWatch.

Filed Under: Meds/Treatments Tagged With: , ,

Recall of Medtronic DBS Component

May 19, 2013 By Leave a Comment
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This was released this month by the National Parkinson’s Foundation and since several are asking for more information regarding the DBS recall, the following article sheds a lot of light on the issue.

NPF Statement on Recall of Medtronic DBS Component
Release date: 5/6/2013

The recall only applies to a component that is used temporarily, typically no more than a month from your first surgery.

The manufacturer of deep brain stimulation (DBS) devices used in the USA and internationally, Medtronic, Inc., of Minneapolis, Minnesota, announced on May 2nd a risk of damage to DBS devices associated with the use of a component used in DBS surgery. The FDA classified this as a Class I Recall indicating high risk to patients. Medtronic had notified physicians of this issue in February.

The component, called the “lead cap” is used to temporarily protect the wire that connects the electrode to the battery pack (the “lead”) during the time between the surgery to implant the electrode and the later procedure to implant the neurostimulator or implanted pulse generator, often called the battery, which generates the electrical pulses that are emitted by the electrode. When the battery is implanted, the lead cap is removed and discarded. Note that this is not the permanent “cap” that is placed over the site where the electrode passes through the skull.

If you have any questions, please contact the National Parkinson Foundation’s free Helpline at 1-800-473-4636 or helpline@parkinson.org, or post in the Ask the Doctor online forum.
— Michael S. Okun, MD, NPF National Medical Director

Read the Medtronic Press Release.

If you have a Medtronic DBS device should you be worried about the “lead cap” recall and what should you know?
This issue could possibly affect Parkinson’s disease and also other patients with implanted devices. Between placing the electrode in the brain and implanting the battery, a neurosurgeon will sometimes temporarily protect the exposed wire or “lead” with a “lead cap,” to protect the lead until the battery is implanted. After the battery is implanted, the lead cap is discarded. It is estimated that only about 20 percent of surgeons even use this cap. The risk is that if the surgeon tightens a screw too tightly on the lead cap, it may damage lead and affect the functioning of the DBS hardware. All implanting neurosurgeons have been made aware of the issue, and a solution is under review by the FDA.

Why did the FDA recall Medtronic devices?
According to Medtronic, they received reports of DBS leads being damaged due to over-tightening of the screw that holds the lead cap in place. The DBS lead cap may be used in DBS and dystonia therapy kits temporarily to protect the end of a DBS lead after it has been implanted. The DBS lead cap is not used in all DBS procedures, and is not permanently implanted. If the lead is damaged, lead replacement may be required or optimal therapy may not be achieved. Only a small number of patients are expected to require lead replacement.

What do patients and families need to know about this issue?
Any damage to the DBS system can be assessed in a minute or two by your doctor in the office setting through use of a portable programming device that can check the integrity of the system. If you have a sudden worsening of your symptoms you should visit your doctor and have the device checked for possible damage.

It is estimated that only a small percentage of DBS systems have been damaged by the lead cap.
Because the DBS system has four small lead contacts that can be used to deliver electricity, it is possible that even if the DBS system is damaged, a different contact can be used for stimulation.

Should I see my doctor to have it checked out?
The damage from this current cap issue occurs at the time of DBS implantation, so patients who have had DBS devices implanted for a while and have been doing well on their therapy should not worry about this recent FDA recall.

Patients can double check their DBS devices for damage during their regular doctor visits. Remember that DBS devices can be damaged after implantation and this damage (fractures and short circuits), if it occurs, will most likely not be the result of this current capping issue which has been addressed by the FDA.

If I have DBS, what should I do? Will someone call me?
Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, weekdays from 7 a.m. to 6 p.m. CST, and the FDA’s MedWatch Program at http://www.fda.gov/MedWatch.

I have one of the devices recalled, will I have to have surgery?
In the case of lead damage, if at the beginning of therapy patients are receiving therapy as expected, they are not likely to be affected by this issue. Patients with questions relating to this issue are encouraged to talk with their physicians.

I am considering DBS surgery, will it affect me? Should I hold off?
No, a manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use DBS lead caps.

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Past Post Revisited – 2010

March 13, 2013 By Leave a Comment

I’ve been gone. Gone to Kentucky for a week, to be with my brother through his hip surgery and hopefully I was some help afterward.Three weeks ago, I was in Montana helping my mom with my dad after his back surgery.

A lot has happened in between then and yesterday. For example, I broke my toothbrush.What?! you may ask.Yes, I broke my toothbrush.It was one of those electric kind that run on batteries and my hand was refusing to cooperate and the harder I pushed, the harder I scrubbed, well… it broke.

And, that was the last straw.I broke down.

For the (I think) first time since being diagnosed five years ago, I was angry and grieving.Through that melt down, I learned several things (not in any particular order).

I am tired.
I cannot do what I used to do.
I can’t cope with disorganization in my life.
I am frustrated that I get distracted so easily.
I want my doctor back.
I came home seeing improvements in the people I cared for, while nothing inside me got better.
I know that things can always be worse.
No matter what does or doesn’t happen, it will not catch God by surprise.

I started this blog about four years ago as more of a journal.During my melt down, I realized I miss that.Sometimes I think I have to be strong and not let others see the struggle within me because of this disease.I have tremors that are becoming more noticeable, but it’s what goes on inside of me that makes others say things like, “You sure don’t look like you have Parkinson’s disease.”

Sometimes, don’t you wish you could switch birth suits so others might have a better understanding?Everyone’s perception of certain diseases is different.Many people don’t realize all the different elements that can be prevalent in Parkinson’s.Depression.Loss of smell.Pain.Loss of mobility in doing basic, simple tasks like tying your own shoes.There’s so much more, but I don’t need to go into that.

The thing is – I love to write.It’s harder now than it used to be.I don’t even attempt handwriting anymore unless it’s signing a card or something similar.Even the computer frustrates me, especially when my ‘mobility’ isn’t cooperating and my mind is racing with ideas.

I love to encourage others because of what I’ve gone through.I believe that God always places someone a little further up on the path of life, so that they are able to help us on our journeys.Someone a little more experienced, a little bit wiser.They come alongside us and there’s an instant camaraderie.The circle becomes complete when we do the same thing for others.

So, even though my discouragement (and sometimes despair) kicks in and beckons me to walk toward the side of the road where discouragement dwells, I’ll remember my list…

-I am tired, but I’m still kicking.
-I cannot do what I used to do, but I am doing something.
-I can’t cope with disorganization in my life, so I am working on simplifying things so I don’t get so frustrated.
-I am frustrated that I get distracted so easily, so I am making a concerted effort to improve my brainpower any way I can.(Anyone have any suggestions?)
-I want my doctor back, but I’m willing to go where God sends me.
-I came home seeing improvements in the people I cared for, while nothing inside of me got better… and that’s okay.
-I know things can always be worse and just might, but…
…no matter what does or doesn’t happen, it won’t catch God by surprise.

So, I guess this is to say, I hope to get back to posting more regularly and more personally as I journey day by day with PD.After all, it’s when we allow ourselves to become transparent that we can do the most good for those coming behind us.

Journeying with you,
~ Sherri

Filed Under: Inspiration/Humor Tagged With: ,

The Dance of Hope – by Judy Hensley

March 11, 2013 By Leave a Comment
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I just caught a few minutes of a show my daughter was watching.It was a dance contest for America’s ‘best dance crew’.The finalist crews’ names were ‘Super Crew’ and ‘So Real Crew’.Each had about 6-8 members.As it showed their journey to the finals, they emphasized that each group had some big hurdles in getting there.

Of course, since my teenage daughter was watching this, it isn’t the type of dance most of us might think of.No cha cha cha, polka, or even disco.No, these young dancers incorporated break dancing and some interesting non-choreographed moves, many of which left you sitting there thinking, ‘That is impossible!’ It only goes to show what the human spirit can do when it is challenged and we devote our effort to a passion – something that is a very part of us, enhanced by the sharing of it with others who are just as passionate.

I was struck by one young man’s statement in his interview about his crew’s performances and their determination to win.He said, ‘You will have to kill us to stop us!’ His crew had come back when others thought they couldn’t win more than any other group in the show’s history – three times.Concerning the other team – one of the judges noted their strong performances and their belief in what they were doing even when some of their family members were not so supportive.He said they believed in themselves, then their crew, and then they made the judges and the audience believe in their passion and their dream.

I stood there and watched just a few minutes, but I was impressed.I thought, ‘These young people may not have been able to do something so impressive on their own, but they worked hard together, taking a shared vision and making it contagious.’They didn’t listen to others who said ‘You’re out of the running!’, but instead stayed with their idea of what would work for them, even when it was atypical to most dance move history.

Now, what these young people have accomplished may not change the world, but it is a shining example of what the human spirit is capable of producing when one believes in oneself, in a common cause, or in success for the future, and all because of seeing that nothing is impossible with those kinds of attitudes.

All that made me think of the times in my life when I’ve experienced a wonderful feeling of contributing to something special.Some of those times include: playing in band in high school, playing on softball and volleyball teams, helping coach a volleyball team that came out of the losers bracket and would not give up in order to win a tournament last year, meeting and talking with others on the internet with Parkinson’s disease, and being a part of the Parkinson’s Unity Walk the last three years.The sports competitions were for personal gratification.The effort I put out for Parkinson’s is a personal passion.

My body has symptoms caused by Parkinson’s and it can make life somewhat more complicated than normal, but I want to stay determined to do all I can to help work toward a cure.I have to believe there will be a cure.I have to surround myself with others who will encourage me not to lose hope – then my spirit will endure!

I won’t make a cure for Parkinson’s disease happen on my own, but with the cumulative power of determined spirits within others who live with Parkinson’s and who want to be a part of something very special one day (a cure), we press on.

Will you believe that we can make a difference?

Will you endure?

Will you join the journey for a cure?

Will you look at each day, determined to find the things that you can rejoice in and revive your spirit?When you can’t seem to find anything joyful in the day, ask a friend to help you find it.Get in the rhythm again.Feel the joy of the dance of life.

The world will look at those of us with Parkinson’s and see us dancing a little bit out of sync on the outside, but they will never know the rhythm of hope we have together unless we can let them see it through our collective efforts of dancing/pulling together.It is then that I think they will see and know that a cure will come, and until it does, that rhythm of hope and belief will be a wonderful healing.

Judy

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What I Learned from My Mom – by Judy Hensley

March 9, 2013 By Leave a Comment
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Becky Good, Judy’s mom

Things I Learned from My Mom

My mother recently passed away from cancer and her life was a great testimony to me. She was the wisest teacher I ever had. She had 72 years of wisdom to pass on to any who would learn, and some pretty good marriage and life lessons from being married to my dad almost 51 years.

Since I am so very proud of my mom, I would like to share some things that I’ve learned from her in my life. Now you see the other end of the spectrum of life from the things Sherri wrote about learning from a 2 year old. Well, maybe they aren’t so different after all.

1. You never ‘back-talk’ or as my Jerzee friends says ‘get fresh’ with your momma. I did it once and remember her reaction well….a hand quickly and firmly smacked my mouth and face and I then looked at her in disbelief! She had never hit me in my mouth…sure, plenty of times on my rear-end, but she must have known how well the shock appeal of this disciplinary action would work. It did the trick on me. Not sure what mom did to my sister for the same problem…whatever it was it took longer to have an effect though.

2. You make a commitment; you keep it. I learned this when I wanted to quit the church softball team I was on because we were awful and winless. Mom said “Oh no, you are not going to quit!!! You play, you have fun…win or lose. Do you need any further motivation?” I replied “no m’am!” So I stayed on the team and ended up having a good time even though we were really pitifull!

3. You do your best, no matter what, even if you come in last or get a low grade. You can’t control how hard other people try but you can certainly make sure that you give your very best at any endeavor you strive to do.

4. One of a woman’s greatest thrills in life is shoe shopping. A good deal on a pair of shoes gives an adrenadine boost like no other….and if you don’t get a good deal then they better be the most ‘make em stop dead in their tracks’ beautiful shoes that are worth every penny of the $$$ you paid for them! Never pass by a shoe store that has a buy-one get-one-free sale! I guess you have to be a female to understand all this. But it is a very important concept of female life to know about.

5. Don’t judge a book by it’s cover. Even if everyone else does, you should know how it feels and resist the temptation to do this. Enough said. This is a hard lesson to learn and put in practice but it will pay dividends you never imagined when you do!

6. Be strong and courageous even when you don’t feel like it. And the way you do this is to draw strength from the LORD. He said he would never leave or forsake us and has sent his spirit as a helper. So use it. It takes courage to face many things in life.

7. Do unto others as Jesus would do to them–and it doesn’t matter if you never get anything in return for doing so. And it is so fun to do random acts of kindness. But no matter how you interact with others, put a smile on your face and let them know you have a reason to smile!!

8. If at all possible, keep your foot away from your mouth–it is entirely possible for it to end up in your mouth and you will most certainly regret it. Stop and think before you speak is a good rule to use.

9. Faith in God is the greatest resource you can have in this life, the hardest thing to explain to others, and the simplest act that provides eternal benefits. Without faith, we have no strength, without strength we have no endurance, without endurance the prize cannot be obtained.

10. Honesty, open-mindedness. loyalty, and laughter are the cornerstones of any good relationship. They don’t just happen, it takes work to cultivate them and help a friendship grow. And we should be friends with our family because that is what God intended.

11. Realize your blessings and give thanks for them and for goodness sakes, share them with others!!!. For there is always something to be thankful for if you look hard enough.

These are just a few lessons that come to mind that I feel like I have been taught by my wonderful mother in the 47 years we had together. I think that by knowing these truths about life, my mother helped prepare me to face life head on and with a confidence that can only be instilled by love. I thank God for her influence, wisdom, and most of all her love that make me feel I was the luckiest girl in the world to have Becky Good as my mom!!!

If your mom is still alive, give her a hug. If she doesn’t live close by, call her up and give her a hug over the phone. And for heavens’ sake…don’t text it to her…let her hear it!

If your mom has passed on, tell someone how much she meant to you, and thank the Lord for the blessing of the time you had with her!!

One of my mom’s pastor’s quoted this verse of Keats as a remembrance of my mom: “A thing of beauty is a joy forever”. And I for one say a big AMEN about my mom in that regard!!!

In memory of my mother, Becky Good, 1938-2010
Judy Hensley

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