Medtronic Receives FDA Letters Over Handling Neuromodulation Complaints

Spine and Orthopedic Devices and Implants

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Medtronic Receives FDA Letters Over Handling Neuromodulation Complaints ^Featured

Written by Jaimie Oh | August 23, 2012

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The FDA has sent warning letters to Medtronic for how it has handled complaints and flaws of its neuromodulation devices, according to a Forbes report.

According to the warning letter, Medtronic failed to correct a flaw in its SynchroMed II infusion pump and properly document and investigate more than 560 complaints about the device.

Medtronic is working to resolve the complaints and implement corrective action to improve its investigative process, according to a company spokeswoman.

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