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.

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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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DBS and Weight Gain

May 2, 2013 By Leave a Comment
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One of my readers contacted me with an interesting question. She asked me if I had experienced weight gain post DBS. She shared that in four months she had gained 15 pounds and has been unsuccessful in getting off the weight.

So, to all of my fellow DBS’ers –

Have you had a similar experience? If so, have you had success controlling it or taking it off and how?

If you have heard about this in your PD circles, can you share?

Thanks so much!

Journeying with you -
sherri

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Do Medicines Treat PD?

April 11, 2013 By 2 Comments
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20130411-110647.jpgYou have been told you have, or someone you love has, Parkinson’s disease. You’ve also heard it is incurable. Nevertheless, can it be treated? If so, what medicines are used in the treatment of Parkinson’s disease (PD)? This question was posed on a site I wrote for and I thought I’d share my article here.

First, let me say, I was diagnosed with PD over five years ago and misdiagnosed over fifteen years ago. As stated earlier, Parkinson’s disease is not curable, but it is treatable – to a degree. Just maybe the day you’ve reached your last degree will be the day they announce a cure.

No one I have ever met likes taking pills and yet, to treat Parkinson’s effectively, there is no way around it for the common patient. Each patient must also understand that PD affects each person differently and so each patient is treated differently and different medications will be used accordingly.

My drug therapy has been conservative, according to my neurologist. For example, one medication (if needed) is added at a time at my check up. This is done so that the physician is able to identify correctly, which medication a patient is reacting to, should side effects occur. This is a much safer procedure than starting with eight pills, three times a day and working backward.

Drug companies/pharmaceuticals would go out of business if they were not constantly coming up with improvements to the treatments already available on the market. That, in and of itself says there is progress being made in treatments for PD and other diseases/illnesses.

While I said earlier that PD is not curable, it is treatable. Treatable, however, will look different for you than it does for another patient. Some will be behind you in their progression of the disease, some ahead. It also depends on how each individual doctor believes or thinks best how the disease should be treated. As you can see, many different factors come into play when a physician must come up with a custom treatment for each patient that will best suit him (the patient).

Of the medications available that physicians choose for their patients, some of the more tolerated and beneficial seem to be Mirapex (although noted with serious side effects for some), Sinemet, Artane, Requip, and Comtan. Other various medications might be added to the mix dependent upon the patient’s symptoms and needs. Those could possibly be Azilect, Lexapro or another anti-depressant (one of the first notable symptoms of PD is depression), Amantadine, etc.

Each patient is unique and different and patients’ needs and reactions to their treatment will be different. What works for one may not be tolerated or work well for another. Hopefully, the drug treatment is scaled to your individual needs and will treat your symptoms, but only your doctor can decide with you what is best and what is needed. New steps are being taken every day and progress is being made at nearly the same rate in working towards a cure. Until then, it is best for patients to follow their regimented treatments until something better comes along. It will if we all keep fighting and do not give up.

Journeying with you –
Sherri

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Are These for Real? ‘Home’ Remedies for Parkinson’s Disease

January 30, 2013 By Leave a Comment
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I received an email today from a woman who is a caregiver to an older woman who has PD and suffers from painful cramps in her toes. She was seeking advice as to what may help alleviate her pain and discomfort. I couldn’t give her any magic potion recipes and nothing definitive that I knew of that would work, so I researched a little bit and found some information that I passed along. Among this information were these ‘homemade’ remedies:

-Try having a glass of lukewarm milk just before going to bed. Though easy, the remedy is very effective in treating foot cramps.

- Having chamomile tea, 5 times a day, can help bring relief from foot cramps, in about 2 weeks. [Editors note: this sounds rather 'relaxing' but beware: if you think frequent trips to the bathroom were a nuisance before, just imagine...]

- Take a hot shower before going to bed, making sure to soak the feet in the water for sometime. It will surely prove effective. [Editor's note: To soak the feet, you may want to plug the drain hole. Why not just take a bath and read a book while you're at it?]

- When you lie down at night, stretch the legs as far as you can and hold the position for a few minutes. Repeat as many times as you can. [Editor's note: THIS EXERCISE GIVES ME CRAMPS!]

- There is yet another exercise that proves beneficial in case of foot cramps. Stand straight, keep your heel on the floor and curl your toes upwards. Hold the position for a few minutes and repeat. [EDITOR'S NOTE: This does not eliminate the pain but increases it - even if I hold the position for less than a few minutes!]

- Red raspberry leaf tea has also proven to be good for treating foot cramps. Have a cup in the morning as well as evening.

- Drink a concoction containing 1 tbsp calcium lactate, 1 tsp apple cider vinegar and 1 tsp honey, in ½ glass lukewarm water, once in a day. [EDITOR'S NOTE: I did not use the word 'concoction'. I have translated the original advice as is, to the 't'. However, this does sound like a crazy concoction for leg or toe cramps.]

- When you go to bed at night or rest in the daytime, carry a hot water bottle with you and use it to apply heat on the feet.

- Consuming 2-3 bananas in a day as well as having 2 tsp of honey daily is another effective home remedy for foot cramps. [EDITOR'S NOTE: I agree with getting the extra potassium, believed to be helpful in reducing leg and foot cramps, but 2-3 a day seems excessive. I have 1 a day or every other day and that seems to help a lot.]

- Use lavender oil, rosemary oil and eucalyptus oil to massage the affected area, once in a day. [EDITOR'S NOTE: I think any oil would feel good. Peppermint works, too.]

- You can also try pressing your toes against the wall and stretching the calf muscles, 15-20 times daily. [THERE IS NO WAY YOU'D GET ME TO DO THIS WHEN MY TOES ALREADY HURT, NOT EVEN ONCE!]

( From Lifestyle Lounge (http://lifestyle.iloveindia.com/lounge/causes-of-foot-cramps-4102.html)

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