St Jude Medical has temporarily pulled its Brio™ Deep Brain Stimulation(DBS) System off the market while it fixes a problem relating to the function of the device apparently caused by bodily fluids seeping into it. The company has issued a “Dear Doctor” letter, which can be found here.
St Jude’s foray into DBS started a few years ago with announcements in 2009 that the company had gained CE mark approval for firstly its Libra and then its Brio devices. Neither device is currently FDA approved.
Back in May 2011 the Brio device was the subject of a first “Dear Doctor” letter relating to a loss of recharging and communication functions. That letter can be found here.
Now the company has identified more problems relating to the same Brio 6788 model, patients having experienced diminished or loss of therapy due to lower-than-expected impedance readings. In total 11 patients were involved, in eight of whom adjustments to therapy settings in the pulse generator did not resolve the issue. This lead the company to the conclusion that the “lower impedance resulted from the intrusion of bodily fluids into the Brio IPG header assembly, creating a conductive path between the active channels”.
What to do
The company letter describes a recommended course of action which includes quarantine and return of unimplanted devices. Patients not showing symptoms of loss of therapy are not being recommended for explantation. For patients who do suffer a loss of therapy, a series of troubleshooting and resetting steps are proposed prior to considering explantation and replacement of the device with a St Jude Libra DBS device supplied at the company’s cost.
The letter closes by telling us that the required changes to the device are expected to take 60-90 days after which time, subject to regulatory approval for the changes, shipments will resume.
Source: St Jude Medical