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yakkwak 08-27-2011 12:05 PM

NEW Pain Pump & Legal Rights as Consumer Issue
Hello friends. Any suggestions on where to turn is appreciated. Couple of weeks ago had new (1st) Medtronic SynchroMed Intrathecal Pain Pump implanted. It is Pump Model Number 8637-20. I am very early in the "titrate-up" on meds schedule so don't see any improvement yet, but that is not uncommon this early. I need suggestion on how to proceed with this issue. I just found out that my particular pump is on recall. [U]In June 2011 [/U](I found letter on the net), Medtronic advised current patients and docs that this model had a bunch of reports of issues with the critical issue and low-medicine alarms, and with the pumps subsequently resetting as a result. There was one issue of death, with a patient who was on Baclofan (spelling?) and died from withdrawal when alarm did not go off. [U]My pump was implanted in August 2011[/U]. I called Medtronic today and they confirmed that all unused pumps with this model # was supposed to have been taken off the shelves by the local Medtronic rep's and not implanted into new patients!!!!!!!!!!!!!!! Needless to say, Medtronic confirms that my individual Serial Number is one of those on recall and my pump was not supposed to be implanted into a patient. [B]With existing patients[/B], they are not advising immediate surgery for replacement unless they have Baclofan medicine in the pump system [U]or[/U] the patient demonstrates specific issues with the warning (the alarm and reset issues). My device currently has morphine in it and not Baclofan. My doc had originally wanted to start me on morphine and if not tolerated, try others - Baclofan was in my original plan as an alternative option. It is not now!!!! obviously. So my question, I guess, is this: I was "sold" a device that is not optimal and limits my choices in the future. I don't think it was right that Medtronic sold me something that requires additional worries and has had an FDA Advisory out on!!!!!! Can Medtronic do this???????????? What kind of advocate can I turn to for assistance so that I don't get the run-around??? Medtronic left a message for my rep to call but I don't expect them to return the call this weekend. I don't want to get an attorney involved if it means it might frighten off my pain management doc. - I need him to stay on my side for obvious reasons. aww gee, and I don't even have my stitches out yet.

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