Schiavo's Implant Potentially Dangerous

by Janice Sanford

Justice1949@aol.com

When a reporter did an article in the St. Petersburg Times, Feb 17,1991. pg.3, about Terri's surgery in which Yoshio Hosobuchi of the University of California at San Francisco in December(1990) implanted neurological thalamic stimulator in her brain, they reported:


"The brain stimulator implant was a success, said her husband, Mike. Mrs. Schiavo is slowly emerging from the coma at the Mediplex Medical Center, a neurological care center in Bradenton, he said. She will undergo at least a year of speech, occupational and physical therapy."
READ HERE

SCHIAVO: She spent three months there. Then, while she was there, we heard of this doctor in California here that was doing experimental surgery, implanting stimulators in people's brains in hopes to stimulate any activity.

Now, we were told with this, too (Ph) when this doctor looked at the CAT scans, that it was probably not going to work Because there's just no brain left. But I did it anyway, because I loved Terri. And I wanted to bring my wife back. I wanted to have my wife back in me.

So I flew her out to California by myself, with a nurse. And I spent a month there. They inserted the stimulator.

KING: Didn't work?

SCHIAVO: No, it eventually didn't work, no. The protocol for the stimulator was three months. I kept it on her for a year.
http://transcripts.cnn.com/TRANSCRIPTS/0310/27/lkl.00.html

From Medical Examiner Jon R. Thogmartin autopsy report on Theresa Schiavo:


...In the left chest wall is an implanted medical device with a wire extending through subcutaneous tissues of the left neck and into the left scalp. A flat, four-prong electrical device is in the subgaleal area of the left scalp. A wire then further extends into the cranial cavity... Autopsy Report

Note: subgaleal area, is the area above the skull or within the scalp layer of the head; ...


Stephen J. Nelson,M.D. (Page 1, last paragraph)
Neuropathology Gross Description:


...A 9 centimeter long implanted neurological thalamic stimulator wire extended outward from the right parietal bone and it was surrounded by a 1 centimeter bony nodule on the inner table. This wire was traced and its tip terminated in the right thalamus... Autopsy Report

9 centimeters = 3.54 inches


OR
____________________


9 centimeters = the length of the(above) line

CT scans

Question:

(Forget about comparing brains for a minute. Where's all the wire and stuff that Dr. Nelson and Medical Examiner Jon R. Thogmartin are describing in their report? )

Chronic deep brain stimulation in its present US FDA - approved manifestation is a patient - controlled treatment for tremor that consists of a multi-electrode lead implanted into the ventrointermediate nucleus of the thalamus.


The lead is connected to a pulse generator that is surgically implanted under the skin in the upper chest.


And an extension wire from the electrode lead is threaded from the scalp area under the skin to the chest where it is connected to the pulse generator.

Most users turn the unit off at night. The stimulus parameters can be adjusted to provide the best response and minimize adverse reactions.


The pulse generator must be replaced to change batteries, which should last 5 years.


Risks of DBS ( Deep Brain Stimulation) surgery are intracranial bleeding, infection, and loss of function.
http://www.pallidotomy.com/deep_brain_stimulation.html

Dr. Nelson seemed to think it was necessary to put in Terri's autopsy report a reason why she "had not undergone an MRI scan of her brain, rather than only a brain scan while alive":


"The FDA has received several reports of serious injury, including coma and permanent neurological impairment, in patients with implanted neurological stimulators who underwent magnetic resonance imaging (MRI) procedures. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. Although these reports involved deep brain stimulators and vagus nerve stimulators, similar injuries could be caused by any type of implanted neurological stimulator, such as spinal cord stimulators, peripheral nerve stimulators, and neuromuscular stimulators"
http://www.fda.gov/cdrh/safety/neurostim.html

One would assume from the autopsy, that an MRIis never done on a patient with an implanted neurological stimulator.


The following is taken from the same report Dr. Nelson quoted from:


If an MRI procedure is to be performed on a patient with an implanted neurological stimulator, be sure to review the labeling for the specific model that is implanted in the patient, with particular attention to warnings and precautions. The radiologist may need to consult with the implanting or monitoring physician for this information. Also note and follow any instructions exactly for MRI imaging that may be in the labeling for the implant, including information on types and/or strengths of MRI equipment that may have been tested for interaction with the particular implanted device. The radiologist may need to consult with the device implant manufacturer for this information.
http://www.fda.gov/cdrh/safety/neurostim.html

According to Michael Schiavo's November 19, 1993 deposition, case No. 90-2908-GD,page 24:

Q And what was the purpose of taking her to California?

A There was some experimental surgery that I heard about.

Q Do you remember the doctor you went to see out there?

A Doctor Yoshio Hosobuchi.

page 25

Q Okay. Tell me about Doctor Hosobuchi and his treatment of Terry?

A Well, the basic thing was we took her to California. He had some experimental stimulators that- he was placing in peoples' heads. There were some people that woke up.

It's a whole protocal on it. I don't have it with me. But it would be very experimental. He put it in. He did some testing. There was no evidence of it working with Terry.

The only thing it would do, when he turned it up passed a certain point Terry would just sit up, which was just motor response. She would just get real bright eyed because things were being stimulated. He wasn't thrilled about it because he didn't see any positive signs.

Q Was -- did he implant anything into her? Did he put anything in her head that remained?

A Yes.

Q Are they still ?

A Yes.

Q What are they?



page 26

A Electrodes. They're platinum electrodes.

Q Did he suggest any future treatment that was experimental --

A Treatment for what?

Q -- in California. Diagnostic testing, anything of that nature?

A No. When Doctor Yingling was here, he came out and, basically, if it didn't work within --



page 27

Q My question was: Was there a suggestion of further diagnostic testing or procedures after the treatment by Doctor Hosobuchi in California?

A As far as I can remember --

page 28

Q Did Doctor Hosobuchi, after he saw Terry, recommend any further diagnostic procedures?

A He recommended that Doctor Yingling would be doing it.

Q So did she see Doctor Yingling?

A She -- Doctor Yingling came out here, I believe, a year later.

Q And that was at the suggestion of Doctor Hosobuchi?

A That, I have no idea.

Q Okay. What did Doctor Yingling say or do, to your knowledge?

A He came out -- Terry was at Mediplex -- he came out and did some testing, and he needed a CP-900 machine or something from Shands, and it wasn't available, and he said it wasn't no big deal.

He told me he had -- he didn'tsee any evident sign that the stimulator was working, did some tests with Terry(i). Nothing was new with her from the time he had last

page 29

seen her. And that was basically it. We took him out to dinner and he had loads of wine and that was it. He spilled it all over our couch.

Q Other than the Doctor Hosobuchi and Doctor Yingling -- was Doctor Yingling also from California?

A Yes.

Q And he was somebody that Doctor Hosobuchi suggested see Terry?

He was Hosobuchi's assistant.

Q Has she seen any other experts since that time?

A What type of experts?

Q Since Doctor Yingling saw her, what physicians have seen her?

page 30

Q Okay. When was the last time Terry had seen a neurologist?

page 31



A I'd have to look up some records. I don't remember.

Q Has it been years?

A No, I don't think it's been years.

Q Has a neurologist seen her since Doctor Yingling saw her?

A I don't recall.

Q Have any diagnostic tests been performed since Doctor Yingling saw Terry?

Q Okay. of the neurology strain.

A I don't recall. There could have been. I don't recall.


According to Schiavo "The protocol for the stimulator was three months" but he "kept it on her for a year." Even though he knew that leaving the stimulator on longer than three months could harm or even kill Terri.

Michael Schiavo should still be made to answer for abusing his wife after her brain injury.

Whether or not the implanted neurological stimulator worked, Michael Schiavo should have made sure that Terri had a neurologist following her case.

The implant had the potential to cause intracranial bleeding, infection, and loss of function.