 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
What's up with the FDA? |
|
|
|
I resigned from Medtronic in December 2005. I tried for several months to help Medtronic quietly correct illegal and unsafe practices. I started to get a funny feeling that Medtronic was merely leading me on, so I called the FDA and asked about how FDA approvals work. They informed me that once Medtronic received FDA approval that it would be very difficult for the FDA to consider pulling a device off the market. I gave Medtronic one last chance to provide evidence that they had addressed the issues without success and therefore reported the issues to the FDA on May 10th. Click the link below for information from the FDA website. |
|
|
|
Link to my complaint on FDA's website |
|
|
|
Either the FDA immediately approved Concerto because of my report or there was an amazing coincidence. In any event, two days later on May 12th (according to the FDA website) Concerto was approved by the FDA. |
|
|
|
FDA link to Concerto Approval |
|
|
|
I began communicating with Rhonda Mecl of the local St. Paul, Minnesota office of the FDA. I provided her some evidence regarding my concerns. Rhonda indicated that she did not have technical expertise and indicated that Tom Lee of the Washington, D.C. office of the FDA would be handling the technical investigation. I called Tom Lee and in our conversation he knew a previous location at which I had worked though I do not recall telling him where I had worked for a previous employer. Mr. Lee also offered the opinion that medical implants do not need to be tested as much as high-reliability commercial cell phone radios. Because of this statement from the FDA, I became concerned that Mr. Lee did not understand the issues. After getting my notes organized I began calling Mr. Lee to ask for a meeting (at my own expense) and tried to get his email contact info from Rhonda Mecl and eventually her supervisor, Cheryl Bigham without success. I did not realize at the time that this information was available on the FDA website. It likely wouldn't have mattered, because Mr. Lee never returned my calls in which I asked to meet with him and his group to help explain the issues. Rhonda Mecl offered to pass on my concerns to Mr. Lee, but the technical details of the problems are complex and easy to misunderstand and miscommunicate by someone not versed in the technology. Nevertheless, I did met with Rhonda Mecl to describe the issues and continued to ask for further communications with and to meet with Mr. Lee into July 2006 without success. Is this how the FDA conducts a thorough investigation?
|
|
|
|
Presentation to Rhonda Mecl in June 2006 |
|
|
|
During my meeting with Ms. Mecl, I provided her email messages and names of engineers who had also expressed concerns about how Medtronic tests their implants. To my knowledge, the FDA has not contacted any of the engineers for a second opinion. A second coincidence? Again, is this a thorough FDA investigation to not contact individuals with evidence. |
|