The FDA this week released notices from Medtronic (NYSE:MDT) warning of software issues with approximately 41,000 cardiac rhythm management devices.
The warnings affect approximately 29,000 EnTrust and Escudo implantable cardioverter defibrillator devices and approximately 12,000 Percepta and Percepta Quad cardiac resynchronization therapy devices, according to urgent field notices sent out by the Fridley, Minn.-based company in June.
The recalls have been labeled as Class 2 by the FDA, and no deaths have been reported related to the issues, according to Medtronic.
The company said that its EnTrust and Escudo ICDs may display warnings that there is not enough battery capacity to deliver high-voltage therapy without having displayed appropriate battery replacement warnings.
Medtronic said it confirmed 25 charge timeout events related to the issue, but that no one has been injured due to the fault.
While the company produced approximately 29,000 of the devices, it stopped production of them in 2010 and said that it estimates only 2,770 of the devices are still active worldwide.
The company advised physicians managing patients with identified devices to schedule patient follow-ups and schedule device replacements as required.
Medtronic also warned of possible device resets with its Percepta and Percepta Quad CRT-Ps due to a timing issue between its EffectivCRT diagnostic and Ventricular Safety Pacing feature.
The issue emerges due to a single reset the device experiences during nightly device checks, which if experienced more than five times will cause a full device reset that can reset the device to default settings, the company said.
Medtronic said it confirmed 105 single reset events due to the issue, and 14 full reset events with no patient deaths or complications.
The company has released a software update to eliminate the issue, and urged users of the device and physicians managing patients with the devices to schedule installations of the update.
Intuitive Surgical CEO Guthart to headline DeviceTalks West 2018
Intuitive Surgical enjoyed a nearly two-decade monopoly in the robot-assisted surgery space. At DeviceTalks West, we'll delve into that history as longtime CEO Gary Guthart tells us how he got his start in medtech, how Intuitive came to enjoy such a commanding lead and what the future holds for medical robotics. REGISTER NOW Use code GUTHART to save an additional 10%. |
MassDevice Network
@MassDevice
LinkedIn
Leave a Reply
You must be logged in to post a comment.