Article #2 re: Medtronic DBS Recall

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Anothher 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

20130519-174642.jpgThis 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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Just for FUN

I cannot remember where this came from, except to say I saw it recently on Facebook. However, whoever did it, for whatever reason, whenever it was done, it fits! I can certainly relate, can you? The ‘sad’ thing is, I’m afraid it might fit even without me having PD! At least ‘we’ have an excuse!

Enjoy!
-sherri

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For Parkinson’s Patients: Getting Help When Filing for Social Security Disability Income (SSDI)

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For about three years now, Ram Meyyappan has been a writer and an …editor for Social Security Disability Help (www.disability-benefits-help.org).

Ram contacted me regarding doing a guest blog post on Parkinson’s Journey on getting help when filing for disability for Parkinson’s patients.

This is her very informative and helpful article for those seeking to hopefully, speed up what can often be a very long, frustrating, and discouraging process in the PD community – filing for disability. I hope you find it helpful and / or can pass it along to others who may be in need of direction in their attempts at filing for disability through the Social Security system.

Thank you, Ram, for reaching out to help those who find it hard to get the help they so desperately need.

Journeying with you – Sherri


Applying for Social Security Disability Benefits Due to Parkinson’s disease

As you likely know, if you have firsthand experience with this condition, people with Parkinson’s disease face worsening symptoms such as muscle stiffness, tremors, and trouble with motor skills. As these symptoms become more severe over time, it will become increasingly difficult, or impossible, for this person to maintain a job. Not only do people living with Parkinson’s often struggle to pay for day-to-day expenses, but they also have to worry about costly medical expenses. This is when having Social Security disability benefits become a major source of relief.

Qualifying for Social Security Benefits With Parkinson’s

Parkinson’s is a special case when it comes to Social Security claims because there is no definitive test or lab report that will prove a Parkinson’s diagnosis. What you can provide is a detailed report provided by your physician – perhaps a neurologist – that demonstrates any physical evidence of your condition, as well as the severity of the symptoms you are facing.

A diagnosis of Parkinson’s disease is typically reached once a physician finds evidence that you are showing signs of at least two of the cardinal symptoms, which includebradykinesia (which refers to slowness of movements), muscle rigidity, and tremors. When determining if someone is eligible for Social Security benefits, the Social Security Administration (SSA) looks for evidence that these symptoms impede significantly on an individual’s ability to complete typical workplace tasks.

People who live with Parkinson’s disease are generally approved for assistance if they are able to provide strong evidence that the condition has significantly made it difficult to stand, lift, walk, or even sit for an extended period of time. A strong Social Security Disability application will typically include documentation provided by medical professionals that show that the applicant is experiencing ongoing and debilitating symptoms in at least two extremities, even though they are undergoing prescribed treatments.

The SSA Blue Book, when listing eligibility requirements, does not specifically address the many emotional and cognitive issues that people experiencing the later stages of Parkinson’s can often experience. However, if these symptoms are making it difficult for someone to understand and follow directions when working, they can be used as evidence in the application process.

Understanding The Difference Between SSI and SSDI

There are two different Social Security Disability Programs for which you can apply: Social Security Disability Insurance (SSDI) and Supplemental Security Income (SSI).The primary difference between SSDI and SSI is that SSDI benefits are accessible to people that are too disabled to work, and who have paid into the system through payroll taxes, and have accumulated enough work credits. SSI benefits are available to people who are disabled, or over 65 years old, but who have a very limited income and who have not accumulated enough work credits to receive SSD assistance. SSI benefits are strictly needs based, and the amount received will depend upon income and the state where the applicant resides.

You can learn more about the two disability programs here:http://ssa-custhelp.ssa.gov/app/answers/detail/a_id/245/~/difference-between-social-security-disability-and-ssi-disability

What to Expect from the Social Security Disability Application Process

It is important to realize that the SSD application process can be quite lengthy. Most people with Parkinson’s disease, who apply, are often denied assistance initially, but a substantial number are then approved for benefits after an appeals and hearing process.

If you, or a loved one, have been diagnosed with Parkinson’s, it is never to soon to begin investigating the SSD application process, as you could be waiting over a year to begin receiving badly needed financial assistance. To improve the chances that you will be granted approval for Social Security disability benefits as soon as possible, it is recommended that you seek legal guidance during the complex application and appealing procedures.

Article by Ram Meyyappan
www.disability-benefits-help.org
Ram Meyyappan
Social Security Disability Help

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DBS and Weight Gain

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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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