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DBS Device Cited by FDA for Flaws

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If you have a Medtronic DBS device should you be worried about the recent

cap recall and what should you know?

The FDA recently announced a recall of a capping device used during deep

brain stimulation surgery. This issue could possibly affect Parkinson's

disease and also other patients with implanted devices. During the DBS

procedure a neurosurgeon will sometimes place a temporary cap on the

device to protect the exposed tip. The cap named in this recall is a

temporary connection device that is used to protect the device in an area

where it is secured to the skull. If a surgeon tightens a screw too

tightly on the temporary protective device, it may damage the DBS

hardware. All implanting neurosurgeons have been made aware of the issue,

and a solution is under review by the FDA. Patients should be aware that

the recall is not for the permanent cap that holds their DBS device in

place. What do patients and families need to know about this issue?

1- 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.

2- It is estimated that only a small percentage of DBS systems have been

damaged due to the current recall.

3- 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 chronic stimulation.

4- If you have a sudden worsening of your symptoms you should visit your

doctor and have the device checked for possible damage

5- The damage from this current cap issue occurs at the time of DBS

implantation, so patients who have had DBS devices implanted and have been

doing well on their therapy should not worry about too much 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.

Michael S. Okun, M.D.

National Medical Director, National Parkinson Foundation

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Dear Dr. Okun,


Like the original poster of the thread, I am looking at the Recall text and a few news releases on it http://www.startribune.com/business/206049721.html ), and see PR and legal obfuscation more than a technical explanation.

I appreciate you comments, but from our own experience, and that of a number of recent posts on your forum, I don't see it go to the heart of the matter for long-term DBS recipients.

Which is the tendency of connector and screws at:

- the IPG - lead extension interface,

- the lead-to-extension interface in the mastoid region (behind the ear),

- IPG pocket adaptors (e.g. Kinetra to Activa PC transition),

- upon fluid penetration below the shield protecting the screws,

- upon heating and thermal expansion of a rechargeable IPG, etc.

to wear out after repeated replacement procedures, and cause irregular current flow to the brain.


So I see the the lead capping-uncapping as the first "attack" on the durability of a connector in the current flow loop. The FDA report isn't forcing Medtronic to determine and disclose a long-term statistical reliability value at this location in the equipment.


Which leads to the following relevant question:

upon replacing an IPG with exhausted battery -- maybe the patient's 2nd or 3rd set -- how clear are the surgical practice and the device manufacturer's instructions on inspecting the lead-extension contact, on not over-tightening or under-tightening those screws, and on proper intra-operative testing of the circuit?


Thank you.

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Thank you for the post. I will be happy to put this up for you for others to comment, but I have no specific answer to your question. My understanding is that all implanting neurosurgeons have been notified but I can't tell you much more than that. I am sorry.

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