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Medtronic's Contradictory Responses |
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There is an FDA website in which you can search for problems with medical implants. The website allows you to search the FDA's MAUDE database. Here is the link to the MAUDE database search engine: |
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FDA's MAUDE Search Engine |
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If you enter CONCERTO as a search term on this website you will receive a list of reported problems. The following links are shortcuts to the items in the database specifically relating to injuries sustained by patients in whom Medtronic's Concerto ICD is implanted: |
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Concerto Patient Injury #1 |
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Concerto Patient Injury #2 |
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Medtronic claims in a Wall Street Journal report from January 30th, 2007 that "We have had no adverse events reported due to the wireless telemetry features of the devices". Where is Medtronic's evidence that wireless issues did not trigger the problems with the devices that injured patients? In fact, the reported injuries are one of the reasons I felt compelled to go public.
According to the Wall Street Journal report, Medtronic spokesman Rob Clark said the company believes the frequency band used by doctors to monitor patients with the Concerto "is dedicated for these uses and we believe it's extremely stable". This statement by Medtronic illustrates a fundamental lack of understanding by Medtronic management of the problem. The issue is with the circuitry, not the frequency band.
There are more discrepancies in Medtronic's story. Medtronic told me in 2006 that they were being investigated by the FDA and asked me if I had reported Medtronic to the FDA. I told Medtronic's attorney that I had reported Medtronic to the FDA (see my FDA link for the reasons). In the following story, Medtronic claims they talked with the FDA regarding the issues I raised.
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Medtronic Talks with the FDA |
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On the other hand, according to a CNNmoney.com story on January 30th, Medtronic spokesman Robert Clark stated "Medtronic has not been contacted by the FDA in regards to an investigation in this matter".
I'm not the only one who has noticed the discrepancies. For more information, I recommend you read the opinion of a cardiologist: |
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More Medtronic Discrepancies |
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