Minnesota medical device giant Medtronic (NYSE:MDT) was the 1st to notify doctors of potential issues with certain of its deep-brain stimulation implants, but the FDA’s response to the warning may have been something of an overreaction, according to some observers.
The federal watchdog agency put its highest-risk Class I label on the recall, a classification generally reserved for warnings in which "there is a reasonable probability that use of these products will cause serious adverse health consequences or death." That doesn’t apply to the Medtronic DBS recall, some doctors said.
"It’s definitely not life-threatening," Ohio State University neuromodulation director Dr. Ali Rezai told the Minnesota StarTribune. "That is really incorrect."
"No one’s going to die," Mayo Clinic neurologist Dr. Bryan Klassen agreed.
Medtronic earlier this year warned physicians of the potential for the wires used with its deep-brain stimulation implants to be damaged during implantation. The devices are used to treat Parkinson’s disease and other disorders. The device company issued the recall after receiving reports that some DBS leads had been damaged "due to twisting of the connector within the lead cap during the surgical procedure," according to the FDA’s warning.
Not all surgeons use the lead cap and not all the lead caps caused damage, so the incidence of the problem is likely low. Medtronic calculated the estimated damage rate at about 0.25%, the Tribune reported, but even in those cases the likelihood of patient harm is slim. Patients may need to have the damaged wires replaced, potentially requiring revision surgery, but in most cases the patient would only experience a return of previous symptoms, not death or injury, Medtronic spokesman Justin Ihle told reporters.
Wall Street analysts seemed similarly unconcerned about the recall. Piper Jaffray’s Thom Gunderson told the Tribune that recalls are business as usual for the medical device industry, and this one is nothing much to fuss about.
"Is this a big deal? No. Is this taking momentum off of neurostim? No. Is this giving the general area of neurostim a black eye? No," Gunderson told the paper. "It is just a normal part of doing business."
Medtronic said the FDA is reviewing its plan to change its manufacturing process to fix the lead problem and has issued modified instructions to physicians on using the DBS lead caps and avoiding damage to the wires. Patients who successfully receive therapy after implantation "are not likely to be affected by this issue," according to the company.
DBS therapy delivers small pulses of electricity to portions of the brain to treat neurological conditions like epilepsy and Parkinson’s. Medtronic won CE Mark approval in the European Union for its Activa DBS device to treat epilepsy in 2010 and released a newer version of the device to treat Parkinson’s the next year. Last year a trial of DBS therapy in treating Alzheimer’s disease was launched using the company’s DBS technology.