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Medtronic receives FDA warning

This article was originally published in Clinica

Executive Summary

Medtronic has been issued with a warning from the FDA relating to quality issues at a Minneapolis, Minnesota plant that manufactures implantable drug infusion and neurostimulation products. In a letter dated July 3, the FDA told Medtronic that inspections of the plant revealed several violations of federal regulations, including: misbranding of devices: an inadequate complaint handling procedure; and failure to report malfunctions with its implantable SynchroMed pump, including catheter separation or fracture, and inflammatory masses and granulomas, all of which could lead to serious injury.

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