Medtronic-

According to a story (subscription required) in the Wall Street Journal, a former Medtronic engineer has alleged that the wireless telemetry features of Medtronic's new Concerto cardiac device were not adequately tested.

At issue is the wireless technology by which doctors and nurses can remotely monitor how well the device is working an dhow a patient is doing. This technology is one of the most cutting-edge of the capabilities of such medical devices, which can cost $30,000 or more.

The former employee, Christopher Fuller, was so concerned that he eventually quit in protest over how the company had done their testing and circumstances surrounding their release of the product.

Last year, Mr. Fuller contacted the FDA and the offices of the U.S.
senators from Minnesota. In one letter to Republican Sen. Norm Coleman,
Mr. Fuller wrote that the Concerto device's long-distance telemetry
"exhibited instabilities in testing" and that Medtronic "has chosen to
ignore the problem."

Medtronic's response to the allegations was not encouraging.

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. We have
had no adverse events reported due to the wireless telemetry features
of the devices."

Regular readers of this site know that claims about "dedicated" frequencies have little impact on the actual operation of a device in the real world. Additionally, Fuller's concerns appear to have nothing to do with the radio frequency chosen for the product. By the way, Medtronic is using MICS (medical implant communications service) frequency specified and regulated by the FCC - more here.

Mr. Fuller contends that this [long distance telemetry] instability can "prevent other circuits
from behaving properly" and can lead to "excessive" battery depletion
or can "burn up" other circuitry in the devices.

Wireless RF medical devices require an entire new realm of core competencies that is lacking in all vendors with little or no wireless experience (that's almost all of them). And the risks of situations like this one that's alleged (and we really don't know why Fuller quit or whether there are any risks with Concerto's wireless feature) is the reason the FDA developed their recent draft guidance on wireless medical devices. I'm sure a crew at Medtronic is pouring over that guidance document to ensure they have all their bases covered.

While this situation reminds some of Medtronic's "What's Inside" direct-to-consumer (DTC)advertising campaign, I'm reminded of Guidant's recent recall. I for one encourage Medtronic to come forth with some information besides, "we're using a dedicated frequency so nothing can go wrong."

You can read more about Medtronic's introduction of the wireless Concerto here. Medtronic's also has a web page on wireless patient management.

Pictured right is Medtronic's gateway device for wireless home connectivity with the Concerto.

UPDATE: According to the St.Paul Pioneer Press, the FDA has completed their investigation of the allegations above and found nothing to indicate the devices are unsafe.

"This investigation included a scientific review of the allegations, an
inspection of the manufacturing facility, a review of the data
previously evaluated in support of the marketing application, and a
review of available adverse event data," she said. "To date, FDA has
found nothing that would have influenced its decision to approve this
device."

This demonstrates that Medtronic followed their own product development processes, including proper design reviews and hazard analyses during the design phase - which is to be expected for a world class company like Medtronic. The only thing lef is for them to keep an eye on their CAPA (corrective and preventive actions) system to ensure that erratic hard to reproduce and track problems - like those alluded to by Fuller - don't start cropping up on their data.