Abbott issues warning for 155K pain relief devices
Abbott has received reports of 73 injuries concerning its Abbott Proclaim and Infinity neurostimulation systems, which deliver low-intensity electrical impulses and are used for chronic pain, the FDA said Sept. 13.
The devices are indicated for spinal cord and deep brain stimulation. The product can be controlled through a mobile app, including halting therapy to begin magnetic resonance imaging. Abbott said some patients have reported being unable to exit the MRI mode from the app, which could require surgery to replace the device.
Customers for about 155,000 Proclaim and Infinity systems have been notified after Abbott recorded 73 injuries and 186 incidents. The company instructed implanting surgeons to advise patients to not delete bluetooth connection between their phone and the device.
Filed under: General Problems
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