Medtronic, Inc.’s Drug Pump Failure Prompts FDA Meeting Request
Implanted pumps made by Medtronic Inc. (MDT) 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.
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.