 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
What do you do when your company tries to make you into a criminal? |
|
|
|
Resignation causing Event: |
|
|
Prelude to Resignation: |
|
|
|
|
|
|
The FCC requires implant companies to perform a Specific Absorbed Radiation (SAR) analysis to determine whether the radio energy absorbed from an implant might be sufficiently high to injure a patient.
Medtronic submitted my name on an analysis report to the FCC in which they intentionally hid problems with the tool used for the analysis. I asked Medtronic to remove my name from the report, but Medtronic refused. It's my understanding that Medtronic didn't want to be delayed by questions the FCC might ask if the FCC became aware of problems with the tool. Because I had already been reprimanded by senior Medtronic management for reporting concerns that Medtronic is planning to violate the law I felt I had no where to turn and no option but to resign. For several years I had been quietly working to help Medtronic realize they were overlooking important safety tests. Once I resigned, I no longer had influence over testing and no longer had visibility. Medtronic refused to provide any concrete evidence to me. Eventually that led to my going public. |
|
|
A few years ago, I reported to my Medtronic management that the Medtronic Regulatory group made the decision to not comply with regulatory labeling laws. It's my understanding that Medtronic didn't want to answer patient concerns they expected to be generated by the required labels. I was reprimanded for reporting the issue to my management. I was punished, not because Medtronic planned to break labeling laws, but because I reported the planned violations via email. Apparently, when discussing intended violations of the law there's an unwritten rule at Medtronic that you call on the phone so as not to create a paper trail.
|
|
|
|
|
|
Labeling Report |
|
|
|
|
|
|
FCC Concerto SAR Report |
|
|
|
Link to FCC copy of SAR Report |
|
|
|
HOMEPAGE |
|