Wednesday, January 31, 2007

Medtronic Concerto Investigation Update

I called Dave Steinhaus, MD, Vice President and Medical Director of the Cardiac Rhythm Management Division at Medtronic yesterday regarding the Concerto allegation and he returned my call about 45 minutes ago. In summary, it seems there were a number of engineering concerns that their former engineer, Christopher Fuller, had regarding the wireless platform that Medtronic implemented for the Concerto device (and also pertains to their Virtuoso ICD). Some of these concerns were addressed, he said, but others were not felt to be of concern to whom he raised issue with at Medtronic. He confirmed that Mr. Fuller then chose to report his concerns to the FDA and a Minnesota senator. Dr. Steinhaus referred me to this news release from Reuters, claiming the FDA investigation is closed.

In essence, their stand at present is that this is a disgruntled employee, and that there has been no failures or complaints of any of their Concerto or Virtuoso implants to date, and they stand by its safety.


Addendum: 1 Feb 2007 1845PM - Regarding the above claim from the Reuters press release that states: "Medtronic said it has had no reports of patient safety issues related to the wireless features of the device." I have checked and found one patient injury reported on the FDA Maude database from the Concerto device dated August 1, 2006 resulting in a patient injury. It can be viewed here. I was unable to see if other reports occurred in 2007. In no way should be construed as being related to Mr. Fuller's allegations, nor related to significant engineering issues with the device.

This one device malfunction in an estimated 11,000 implants is well below the prior reported average of 20.7 device malfunctions in 1000 implants noted by the prior report of the Heart Rhythm Society's Task Force of Device Performance Policies and Guidelines. - Wes


Anonymous said...

Internal Medtronic Defibrillators
On February 3rd 2005, Medtronic announced the recall of several models of it's implanted defibrillators. The devices were recalled because they are prone to battery shortages which can cause them to fail, presenting a life-threatening situation. The battery problem affects Medtronic's Marquis line, which includes the brand names Marquis, Maximo and InSynch. It is estimated that as many as 87,000 of these devices were implanted in patients before 2003.
Medtronic is alerting recipients of defects in the following defibrillator models:
* Micro Jewel II Model 7223Cx
* GEM DR Model 7271 implanted cardioverter-defibrillators
* 7230 Marquis VR
* 7274 Marquis DR
* 7232 Maximo VR
* 7278 Maximo DR
* 7277 InSync Marquis
* 7289 InSync II Marquis
* 7279 InSync III Marquis
Medtronic Catheter Recalls:
* Model 8731 Intrathecal Catheter (July 2006)
* Model 8598 Intrathecal Catheter Distill Revision Kit (July 2006)

The list goes on, and on, and on, and on....... "Discruntled Employee"... my yoohoo!!!! When is the the FDA and, or representatives of these corporations going to stop and listen! It's a shame that so many choose to be so unkind and make ill remarks for true honesty these days just to make a buck! I highly doubt a discruntled employee would quit his job on his own and then mis-represent information that he himself was to complete testing on. I think in effect you have a truly honest, caring individual who does not want to hear of more people suffering, and or dying due to defective devices which were released through these device manufacturers without the proper test performed! Medtronic is one that has certainly shown it's inibilty through the years to do the responsible thing. This itself can be scene by their own recalls. The should at least appreciate the fact someone is trying to tell them to perform higher grade testing for such devices and that it should be the higher priority. To many manufacturers are releasing devices to early. Who is going to make them accountable when lives are at stake? and Who better to set accurate guidelines and parameters for testing then the individuals testing said devices. It sounds like Medtronic is in serious need of re-evaluating Quality level's for releasing devices without proper testing. I assumed these devices were made to save lives not harm them!? It's clear... the truth is by verification. I think Chris Fuller knew this and decided not to play anymore. If anything maybe the discruntled party is Medtronic. Do me a favor... Google "Defective Medtronic Defibrillators and Pacemakers" See what you can verify on your own and base your conclusion from there... Do not base them on what a VIP from a manufacturere has to say! :)
Signed, A Kinder Caring Average Person. Lets get real!

Anonymous said...

Hi, Chris Fuller here.

The last thing I am is vindictive towards Medtronic. Medtronic's products have saved many lives over the years. I resigned in protest in December 2005 because Medtronic refused to perform standard, basic radio tests on a high reliability, life critical device that a cell phone manufacturer would perform. How do I know this? I performed more different tests on the Concerto RFIC than anyone at Medtronic or elsewhere. I did everything I could to try to not go public with the issues. I tried for years in vain to help Medtronic understand the need for additional testing. I tried for five months (Dec '05-May'06) following my resignation to help Medtronic quietly address the risks. I warned Medtronic that I was going to go to the FDA if they did not rectify the quality and safety problems, but Medtronic refused to provide any evidence that they had taken my concerns seriously. The response of the FDA was equally frightening. The lead technical investigator, Thomas Lee, only communicated with me once at the beginning of the investigation and in that discussion he clearly stated that medical implants do not need to be tested as much as cell phones. I attempted many times to meet with Mr. Lee and provide detailed technical information, but he refused to return my calls and refused to meet with me. I provided the FDA the name of another Medtronic engineer that shared my concerns and who indicated a willingness to talk with the FDA. That employee was fired by Medtronic within 48 hours of my providing his name to the FDA and the FDA never made any attempt to contact him. These actions and many others by the FDA and Medtronic (too much to write here) were reported to former senator Dayton. He reported my concerns to the Health and Human Services Office of Inspector General who initiated an investigation. Last week I logged into the FDA MAUDE website for the first time and noticed a Concerto patient has been injured. I don't have all the info on the incident, but an instability in a concerto could potentially be manifested in higher noise in the rate sensor which could potentially make a pacemaker go into tachycardia. I again gave Medtronic an opportunity to quietly prove that they have addressed the issues, but Medtronic turned me down. I have been warned by an attorney that I could be sued on trumped up charges by Medtronic until I am bankrupt. Regardless of the consequences to me, in the interest of human life safety, I have no choice but to warn the public of the issues. So call me disgruntled if you will, my conscience is clear.

DrWes said...

Chris -

Thank you for taking the time to make a statement here. It is very helpful to understand all of the sides of the issue.


I reported what was told to me. To be fair, EVERY device manufacturer out there has had their series of device recalls at one time or another. Medtronic's battery recalls are old news, and to their credit, a root cause was identified and corrective action taken. With the complexity of newer devices, no doubt new recalls will surface in the future.

The current circumstances of these allegations are not for me to decide. I only tried to get the response from Medtronic regarding the WSJ article that exposed Mr. Fuller's allegations.

What has been abundantly clear from all of the prior recalls is that a level-headed approach to dealing with these situations is required. Patients lives are at stake - but a hysterical reaction to the allegations and fear-mongering the public may be just as harmful for those with devices. I was reassured by Medtronic that the FDA and FCC have investigated the claims made by Mr. Fuller. Certainly there are those who will take their comments with a grain of scepticism, but I just reported what was told to me.

I agree that it is difficult to understand why an employee with Mr. Fuller's credentials would resign and expose himself as he has, unless he felt there was merit to his claims that went unheeded. But engineering these devices is a complex art, with more than one way to build components, and as such, each step of the design process must be reviewed and discussed amongst teams of engineers - some of which are bound to disagree with certain design elements. I for one, do not pretend to say that I have any data regarding the allegations, but as a physician responsible for patients with these devices, I feel it is my obligation to report what I know.

Regarding your comment "who is going to make them accountable when lives are at stake?" You can bet the legal system will have a heyday if these allegations are shown to have merit. But realize that these devices are generally miraculous and save countless lives daily. Certainly there have been and will continue to be recalls. But in the patients we implant, we feel the benefit to these devices outweighs their risks. If there is a device that is found place patients at an increased risk, based on disclosed information, we move to another manufacturer - witness Boston Scientific's loss of market share of their devices with their recall.

It is quite possible that additional information will come to light regarding this case, and rest assured I will be sure to report it as objectively as possible.

Anonymous said...


Chris Fuller here again. I appreciate your objectivity and I agree with much of what you have written. Medtronic's products have saved many lives and they provide therapies that no one else cares to provide even in some cases products which make them no money. Scare mongering and misinformation is only going to cause harm to patients.

Specific to device safety, I have evidence that Medtronic failed to perform standard and customary tests and that the device went unstable during testing. I have never indicated that test results show that therapy was affected. In my past an unstable circuit destroyed itself. Therefore, my concern is that Medtronic has not evaluated the device sufficiently to know what might happen. I am also very concerned about Medtronic's openly illegal behavior.

I can tell you that every experienced RF engineer that worked on Concerto had concerns about how Concerto was tested. In fact, I was not the most vocal RF engineer raising concerns within Medtronic. I have emails expressing concern by or discussing concern of all experienced RF engineers. Even with a consensus from all experienced RF engineers that testing was inadequate as compared to standard practice, Medtronic management refused to consider additional testing. This week Medtronic admitted to the media that they adopted some of the concerns I raised. I do not recall Medtronic ever telling me that they implemented any of my recommendations, except correcting their illegal labeling practices.

Medtronic refused to share the results of their additional efforts with me and expected me to take their word that they acted appropriately. If Medtronic had not behaved so unethically and illegally I might have taken them at their word. Even so, I gave Medtronic every opportunity to resolve the issues quietly.

One last comment regarding FCC violations, you can search the FCC website for Medtronic's FCC submissions. You will find almost no submissions for the time period prior to 2003. Every Medtronic device prior to 2003 was required to have a license or a waiver. None of Medtronic's devices were operating legally in the U.S. or Europe for most of the history of the company. Medtronic was well aware of their illegal behavior because they once performed FCC testing for other companies (a function spun off to the company TUV in Wisconsin in the 1980's). Medtronic refused to properly label their devices, again an FCC and European violation. Part of my job was to help Medtronic get legal with the FCC and in Europe. In that I accomplished my job (though I had to resign to complete the job).

I have nothing to gain personally or professionally from going public and everything to lose. I consider it a personal failure on my part that I was unable to convince Medtronic to consider patient safety first.

I have faith the truth will eventually come out. I am happy to provide evidence supporting any of my allegations. I realize it's hard to believe what I say. It's true that the craziest things happen in bad fiction and real life.

Chris Fuller