Medtronic’s Drug Pump Failure Prompts FDA Meeting Request
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Implanted pumps made by Medtronic Inc. to deliver painkillers and drugs may corrode and fail, said U.S. regulators who requested a meeting to discuss the issue.
The Food and Drug Administration letter stems from an inspection at the neuromodulation unit for Minneapolis-based Medtronic that concluded May 9 and found corrosion in the SynchroMed II pump can cause the motor to stall or seize.