Errors In Medical Device Result To Failures. Medtronic Deep Brain Stimulation Devices Chargers Malfunctioning. Medtronic has warned that some of its Model 37751 rechargers for its deep brain stimulation devices may be malfunctioning.
In an “Urgent Field Safety Notice” addressed to healthcare professionals this month, the company said that the rechargers may become unresponsive and fail to fully recharge the device until they are reset.
According to the letter, some customers reported that their rechargers have stopped working; they bleep every five seconds while displaying a blank screen.
This “error state” appears to be more common in rechargers manufactured since November 2014. Medtronic says 2 percent of chargers manufactured since November 2014 are prone to error state, while 0.2 percent of chargers manufactured before November 2014 are susceptible. Rechargers manufactured November 2014 and later contain serial numbers beginning with “NKA4” or “NKU4”.
During the error state, the recharger is unable to recharge the deep brain stimulation devices. Until the rechargers are reset, they cannot recharge the neurostimulator. Deep brain stimulation therapy is used to treat various neurological symptoms, such as movement problems associated with Parkinson’s disease and epilepsy.
Loss of Deep Brain Stimulation Device Can Lead to Life-Threatening Problems
Medtronic warned that the neurostimulator will stop delivering therapy if the battery is depleted, and patients may experience a return of neurological symptoms. In some cases, the company said, the loss of deep brain stimulation can lead to life-threatening injury and death.
For instance, patients with Parkinson’s disease may experience akinetic crisis (severe inability to move) and patients with epilepsy may experience status epilepticus (where seizures last too long or seizures follow one another without recovery) without neurostimulation. So far, the recall has not been linked to any life-threatening injuries or deaths.
The company says the rechargers should be plugged into the AC power supply before recharging the neurostimulator and should remain connected until the charging is complete in order to prevent the error state.
If the recharger is unresponsive, the company advises healthcare professionals to help patients reset the recharger. Physicians should notify their patients of the recharger issue and discuss how to address the problem, the letter states.