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Medtronic responds to FDA warning on CRDM division

This article was originally published in Clinica

Executive Summary

The US FDA has sent Medtronic a warning letter after an inspection of the company's cardiac rhythm disease management (CRDM) operations in Minnesota in August raised a number of concerns. The issues are related to Medtronic's procedures for identifying, preventing and correcting problems with CRDM devices; the company's timeliness for reporting these problems to the FDA; the documentation of the field action; and quality control of suppliers. Medtronic had to recall around 34,000 pacemakers in May due to potential wiring defects (www.clinica.co.uk, June 12 2009).The firm said on Wednesday (November 18) that it will respond to the warning letter within 15 days, as required. It added that it has started to implement changes, and that the FDA had noted the company's efforts in its warning letter and deemed them "adequate". This is not the first time that the agency has criticised the top medtech manufacturer over its tardy response to product recalls – in June, the FDA revealed that the company took over two years to issue a recall of faulty drug and insulin pumps (www.clinica.co.uk, June 29 2009).

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