Refused to assume care by St Jude Medical leadless

I moved to MI Oct5, 2013 for safe access to Medical Marijuana. While in MI I required a 4th ablation to treat SVT, that left me Brady, requiring a PM. Dr. Ip approved me as a Nanostim recipient, knowing that I'm a MMJ pt (documented by him), which I received 7-10-14. I've relocated back to KY two moths ago. Two st jude medical sites have refused to assume my care under the trial. No reasons given. I've been told to return to ?MI to be interrogated every 6 months.
Last month I had sustained Brady with Nanostim, still no answers, no willing doctor in the state.
What to do? I need to be interrogated by feb. 6th for the study, but I have 36 bucks for the gas tank.
So frustrated by my zip code. Has anyone else participated in a study?

6 Comments

study

by Tracey_E - 2015-01-20 08:01:48

Didn't they spell out follow up to you when you agreed to be part of the study? I'm not surprised you can't find just anyone to treat you. They're very new and most drs don't know much about them yet so it's going to be hard to find someone until they are more common. Is there a way to interrogate remotely?

Follow up

by MaryJaneSparks - 2015-01-20 08:01:58

I was prearranged to be seen at the Lexington site, two months prior to moving. The Cincinati site just turned me down today. There are 50 sites in the Nation.

CE - Clinical Engineer's

by PacerRep - 2015-01-20 10:01:59

These are the only people that are qualified to check your device. A normal St Jude rep should not touch it, as it would require an adverse incident report and eliminate you from the trial. Once eliminated, typically your implant is seen as a failure and that goes against the trial statistics.

That being said, this is not your problem.

Call St Jude. 800-681-9293 and speak to their customer service. If you don't get the answers you need call direct into Tech Support (no need to explain how you got this number please) 800-722-3774. Here's your POA (plan of action).

1). Ask them, where can I get this checked? They should have a list of sites with Engineers available in your area. If none are available, my position would be, fly one in. I have worked on the clinical side and I had elite status on almost every airline. That's all we do is fly around checking stuff and covering cases.

2). If they are not responsive, I would advise them that your next steps will be to file a complaint on BBB.com and then with the FDA. The last thing they want is a complaint by a patient on an investigational device not being serviced.....bad bad bad.

3). Finally, HardBall. Do you know who Barry Meier is? Maybe not, but everybody in the industry does. He works for the New York Times, and he hates every single one of us. We are evil, no good, greedy scumbags to him, and he lets the world know it. It's his personal crusade to take down the device industry. Send him a note on your situation if they won't help you =).

Contacts

by MaryJaneSparks - 2015-01-21 12:01:49

Have contacted all of the above, including the FDA, however, the Nanostim is not FDA approved.
No response from st jude medical since Thursday. Calling everyday, multiple departments.
Local doctors are helping me.

6.5 hour drive

by MaryJaneSparks - 2015-01-22 07:01:53

No return communications from st jude medical. It's expected of me to return the original site? I have no freedom to move?? There is 50 st jude medical leadless sites in the Nation.

Just began with study

by tammyjk1021 - 2015-01-24 10:01:12

Mind you I have just began with my study but my best contact with all the answers has been the first person I had contact with from Medtronic. I had someone assigned to track me and I am assuming you had the same. They definitely don't want you to just drop out. Since I just had my pacemaker put in a few days ago, it's pretty fresh in my memory....they did tell me they could travel to accommodate me. Luckily for me, I'm not moving and the young lady assigned to track me lives within 1 mile of my home.

All of the paperwork I got before the procedure spells out the terms in a very detailed manner. I would refer back to that first. Your doctor should be able to direct you to another physician that is approved to treat you.

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